What this pack is
DIOVAN HCT is the brand name in this record; valsartan and hydrochlorothiazide is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
DIOVAN HCTGeneric namevalsartan and hydrochlorothiazide
How this medicine works
The current label explains that valsartan selectively blocks angiotensin II effects at the AT1 receptor, while hydrochlorothiazide reduces sodium and chloride reabsorption so more sodium and water leave in urine. Combining both paths in one tablet does not let the site split or rebuild an individual's regimen from a blood-pressure number.
Read source: United States ↗Current regulatory record · reviewed 2026-08-29More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- DIOVAN HCT
- Generic name
- valsartan and hydrochlorothiazide
- Dosage-form class
- Valsartan/hydrochlorothiazide fixed two-ingredient film-coated oral tablets: 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg; each pair states the two ingredients in one tablet
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
5 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current U.S. DailyMed public label (SPL v34, effective 13 Feb 2026; verified 29 Aug 2026)
Valsartan 80 mg plus hydrochlorothiazide 12.5 mg per tablet; 90-tablet bottle
- Product code
- NDC 0078-0314-34
- Form and route
- DIOVAN HCT valsartan/hydrochlorothiazide film-coated oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- valsartan
- 80 mglabelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction
- hydrochlorothiazide
- 12.5 mglabelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products
- Package
- 90 tablets per bottle
- Labelled appearance
- light orange · ovaloid film-coated tablet, about 10 mm; unscored · imprint CG / HGHUnscored; do not infer permission to split it
United States label · Current U.S. DailyMed public label (SPL v34, effective 13 Feb 2026; verified 29 Aug 2026)
Valsartan 160 mg plus hydrochlorothiazide 12.5 mg per tablet; 90-tablet bottle
- Product code
- NDC 0078-0315-34
- Form and route
- DIOVAN HCT valsartan/hydrochlorothiazide film-coated oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- valsartan
- 160 mglabelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction
- hydrochlorothiazide
- 12.5 mglabelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products
- Package
- 90 tablets per bottle
- Labelled appearance
- dark red · ovaloid film-coated tablet, about 15 mm; unscored · imprint CG / HHHUnscored; do not infer permission to split it
United States label · Current U.S. DailyMed public label (SPL v34, effective 13 Feb 2026; verified 29 Aug 2026)
Valsartan 160 mg plus hydrochlorothiazide 25 mg per tablet; 90-tablet bottle
- Product code
- NDC 0078-0383-34
- Form and route
- DIOVAN HCT valsartan/hydrochlorothiazide film-coated oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- valsartan
- 160 mglabelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction
- hydrochlorothiazide
- 25 mglabelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products
- Package
- 90 tablets per bottle
- Labelled appearance
- brown orange · ovaloid film-coated tablet, about 14 mm; unscored · imprint NVR / HXHUnscored; do not infer permission to split it
United States label · Current U.S. DailyMed public label (SPL v34, effective 13 Feb 2026; verified 29 Aug 2026)
Valsartan 320 mg plus hydrochlorothiazide 12.5 mg per tablet; 90-tablet bottle
- Product code
- NDC 0078-0471-34
- Form and route
- DIOVAN HCT valsartan/hydrochlorothiazide film-coated oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- valsartan
- 320 mglabelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction
- hydrochlorothiazide
- 12.5 mglabelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products
- Package
- 90 tablets per bottle
- Labelled appearance
- pink · ovaloid film-coated tablet, about 18 mm; unscored · imprint NVR / HILUnscored; do not infer permission to split it
United States label · Current U.S. DailyMed public label (SPL v34, effective 13 Feb 2026; verified 29 Aug 2026)
Valsartan 320 mg plus hydrochlorothiazide 25 mg per tablet; 90-tablet bottle
- Product code
- NDC 0078-0472-34
- Form and route
- DIOVAN HCT valsartan/hydrochlorothiazide film-coated oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- valsartan
- 320 mglabelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction
- hydrochlorothiazide
- 25 mglabelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products
- Package
- 90 tablets per bottle
- Labelled appearance
- yellow · ovaloid film-coated tablet, about 18 mm; unscored · imprint NVR / CTIUnscored; do not infer permission to split it
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
DIOVAN HCT label reading: the two numbers are two ingredients; check duplicate valsartan and diuretics first
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
Each DIOVAN HCT tablet contains fixed amounts of valsartan and hydrochlorothiazide. For example, 160/12.5 mg means 160 mg and 12.5 mg of the two ingredients in one tablet; it is not a half-tablet cue, a two-tablet cue or a sum that can be directly converted across products.
- Check the active ingredients on every pack. DIOVAN is valsartan alone and MICROZIDE is hydrochlorothiazide alone; EXFORGE, EXFORGE HCT, ENTRESTO, HYZAAR and AVALIDE may also share an ingredient with this product. If they appear together, do not remove or add a pack yourself; a pharmacist or prescriber must review the complete prescriptions.
- Dizziness, fainting, marked weakness, thirst, clearly reduced urine, persistent vomiting or diarrhoea, muscle weakness or cramps, or an abnormal heartbeat may accompany changes in blood pressure, fluid balance, kidney function or electrolytes. Use local emergency services for severe or sudden symptoms or altered consciousness.
- Do not use potassium supplements or potassium-containing salt substitutes without professional review. Lithium, NSAIDs such as ibuprofen or naproxen, other medicines affecting the renin-angiotensin system and other diuretic or blood-pressure medicines require review against the full medicine list, especially in older adults, volume depletion or kidney impairment.
- Sudden eye pain, rapidly reduced vision or marked blurred vision requires prompt medical assessment. Swelling of the face, lips, tongue or throat, breathing difficulty or fainting requires local emergency services.
- The label carries a boxed warning for fetal toxicity. Anyone who is pregnant, may be pregnant or plans pregnancy should contact the prescribing team promptly; do not wait for a website decision or use the site to arrange stopping or switching.
- The label advises sun protection and skin screening as clinically directed for hydrochlorothiazide users. This does not mean skin cancer will occur and is not a reason to stop treatment independently.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-29
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 2
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. DIOVAN HCT valsartan/hydrochlorothiazide public label (Novartis; SPL v34, effective 13 Feb 2026) ↗Current regulatory record · reviewed 2026-08-29
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-08-29Current FDA Orange Book data: DIOVAN HCT, NDA 020818; all five oral-tablet strengths are listed as prescription RLD products ↗reviewed 2026-08-29
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about DIOVAN HCT (valsartan and hydrochlorothiazide). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
DIOVAN HCT is the brand in this record and valsartan and hydrochlorothiazide is the active-ingredient name. Check both with the dosage form (Valsartan/hydrochlorothiazide fixed two-ingredient film-coated oral tablets: 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg; each pair states the two ingredients in one tablet) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): current U.S. DIOVAN HCT valsartan/hydrochlorothiazide public label (Novartis; SPL v34, effective 13 Feb 2026) ↗Current regulatory record · reviewed 2026-08-29
- Current FDA Orange Book data: DIOVAN HCT, NDA 020818; all five oral-tablet strengths are listed as prescription RLD products ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How the two ingredients work together: one blocks angiotensin II signalling and one increases sodium and water excretion
- Valsartan can affect potassium and kidney function; hydrochlorothiazide can cause low potassium, sodium or magnesium and affect urate, glucose, lipids and calcium. The words 'blood pressure' must not replace symptoms, laboratory review and the complete medicine list.
- The five paired strengths are five complete product identities. Different milligram pairs, colours, imprints and NDCs cannot be converted by the site into an individual increase, decrease, split, make-up use or alternation plan.
- Older adults and people with kidney or liver impairment, diabetes, gout or volume depletion particularly need professional review using the actual packs and monitoring results; the site does not generate a regimen from age or laboratory values.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): current U.S. DIOVAN HCT valsartan/hydrochlorothiazide public label (Novartis; SPL v34, effective 13 Feb 2026) ↗Current regulatory record · reviewed 2026-08-29
- Current FDA Orange Book data: DIOVAN HCT, NDA 020818; all five oral-tablet strengths are listed as prescription RLD products ↗reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
DIOVAN HCTvalsartan and hydrochlorothiazide
This page includes an exact current U.S. public-label package panel for DIOVAN HCT, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Original approval of 80/12.5 mg and 160/12.5 mg
Current Orange Book data list both strengths as NDA 020818 products 001 and 002 and prescription RLD products.
Current FDA Orange Book data: DIOVAN HCT, NDA 020818; all five oral-tablet strengths are listed as prescription RLD products ↗Approval of 160/25 mg
Current Orange Book data list this strength as product 003 and a prescription RLD.
Current FDA Orange Book data: DIOVAN HCT, NDA 020818; all five oral-tablet strengths are listed as prescription RLD products ↗Approval of 320/12.5 mg and 320/25 mg
Current Orange Book data list both strengths as products 004 and 005 and prescription RLD products; 320/25 mg is also the RS.
Current FDA Orange Book data: DIOVAN HCT, NDA 020818; all five oral-tablet strengths are listed as prescription RLD products ↗Current SPL v34 became effective
The current DailyMed page retains five strengths, packs, appearances, the boxed warning, interactions and other label-reading routes.
DailyMed (NLM): current U.S. DIOVAN HCT valsartan/hydrochlorothiazide public label (Novartis; SPL v34, effective 13 Feb 2026) ↗
MARKET SCOPE
Market-record boundary
United States
Current DailyMed brand label; all five strengths are listed as prescription RLD products in the Orange BookThis page displays five 90-tablet bottle panels; the label does not establish stock at a particular pharmacy or purchasing eligibility.
Mainland China and other markets
Current market record not establishedNo local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients or milligram numbers.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Does 160/12.5 mg mean splitting the tablet in half?
No. It means one tablet contains valsartan 160 mg and hydrochlorothiazide 12.5 mg. The label lists the tablets as unscored, and the site does not convert the paired numbers into splitting or an individual tablet count.
Can DIOVAN or MICROZIDE be taken in addition to DIOVAN HCT?
The website cannot decide for an individual. DIOVAN HCT already contains valsartan and hydrochlorothiazide, so an additional single-ingredient product may be duplicative or intentionally prescribed; only exact prescriptions, packs and the complete medicine list can establish that. Do not add or stop a pack yourself.
Can the five products be substituted by colour?
No. Colours and imprints correspond to different two-ingredient strengths and NDCs. Colour is only an appearance clue and does not establish authenticity, suitability or interchangeability.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.