What this pack is
LITHOBID is the brand name in this record; lithium carbonate 300 mg extended release oral tablet is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
LITHOBIDGeneric namelithium carbonate 300 mg extended release oral tablet
How this medicine works
Lithium's clinical effects involve several cellular-signalling pathways, but a mechanism explanation does not replace serum-lithium monitoring and cannot use mood, sleep, one test result or prior use alone to decide continuation, stopping, switching or co-use with another psychiatric medicine. For ordinary readers, first separating the exact dosage form and every co-medication is safer than guessing an individual plan from mechanism.
Read source: United States ↗reviewed 2026-09-13More 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
- LITHOBID
- Source-scoped market brand names
- LITHOBID · United StatesSource-scoped evidence ↗300 mg extended-release oral tablet under NDA 018027; the reading document is the U.S. public label effective 28 Oct 2022.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- lithium carbonate 300 mg extended release oral tablet
- Dosage-form class
- Lithium carbonate film-coated extended-release oral tablets. 300 mg is the labelled amount per tablet; extended-release tablets, immediate-release oral lithium products, lithium citrate oral liquid, other-market products and other lithium salts are not the same product for self-conversion, combination, alternation or substitution by name or milligrams.
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
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.
1 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 · U.S. public-label effective version: 2022-10-28
300 mg lithium carbonate per tablet; not an individual's tablet count, schedule or adjustment plan
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 62559-280-01 / NDA 018027
- Form and route
- LITHOBID lithium carbonate 300 mg film-coated extended-release oral tablet · oral
- Listing review
- Cited product evidence reviewed 2026-09-13; actual marketing, stock and availability are not established.
- lithium carbonate
- 300 mglabelled amount per tablet; not an individual-use instruction
PACKAGE-VISUAL STATUS
Exact product identity retained; no look-alike lithium-salt pack or tablet image substituted
The public label supports checking the NDC, dosage form, per-tablet amount, 100-tablet bottle and imprint clues, but no displayable principal pack image was retained one-to-one for this version, NDC and a primary public source. To avoid presenting an immediate-release tablet, lithium citrate liquid, another-market product or source-uncertain image as LITHOBID, this page withholds pack and tablet imagery.
LABEL READING · NOT A PRESCRIPTION
LITHOBID enlarged label: first separate extended release, 300 mg per tablet and monitoring boundaries
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.
This U.S. label is for a 300 mg extended-release lithium carbonate tablet; 300 mg is the amount per tablet and 100 tablets is the package count. Neither tells an individual how many tablets or when to take them. Lithium-toxicity risk is closely related to serum lithium concentration; use the exact pack, prescription and complete medicine list with the responsible team, not a website, similar name or leftover medicine, for any adjustment.
- An extended-release tablet is not an immediate-release lithium carbonate tablet or a lithium citrate oral liquid. A shared ingredient or the word “lithium” does not establish self-conversion, substitution, combination or alternation by milligrams.
- Diuretics, ACE inhibitors/ARBs, NSAID pain medicines, dehydration, diarrhoea, vomiting, fever, marked food/fluid changes or kidney-function changes can make lithium-related risk a priority for professional review; the site generates no pause, catch-up, spacing or dose-change instruction.
- Marked tremor or unsteadiness, slurred speech, severe drowsiness or confusion, persistent vomiting/diarrhoea, fainting, abnormal heartbeat, breathing difficulty or inability to remain safe requires local emergency or medical support immediately with every medicine pack; do not wait for a website assessment.
- Tablet colour, imprint, a score line or “100 tablets” can only help check exact product identity. A score line itself does not permit self-splitting, reducing or changing the product.
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 · 2026-09-13
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): U.S. public label for LITHOBID (lithium carbonate) 300 mg film-coated extended-release oral tablets (ANI Pharmaceuticals; effective 28 Oct 2022) ↗reviewed 2026-09-13
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 · 2026-08-29FDA Orange Book data files: LITHOBID (lithium carbonate) NDA 018027, 300 mg extended-release oral-tablet RLD/RS product entry ↗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 LITHOBID (lithium carbonate 300 mg extended release oral tablet). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
LITHOBID is the brand in this record and lithium carbonate 300 mg extended release oral tablet is the active-ingredient name. Check both with the dosage form (Lithium carbonate film-coated extended-release oral tablets. 300 mg is the labelled amount per tablet; extended-release tablets, immediate-release oral lithium products, lithium citrate oral liquid, other-market products and other lithium salts are not the same product for self-conversion, combination, alternation or substitution by name or milligrams.) 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): U.S. public label for LITHOBID (lithium carbonate) 300 mg film-coated extended-release oral tablets (ANI Pharmaceuticals; effective 28 Oct 2022) ↗reviewed 2026-09-13
- FDA Orange Book data files: LITHOBID (lithium carbonate) NDA 018027, 300 mg extended-release oral-tablet RLD/RS product entry ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How lithium carbonate works: mechanism reading does not replace lithium level, kidney function or full-list review
- Being called a mood stabiliser does not make medicines the same. Lithium carbonate, valproate, lamotrigine, antipsychotics and antidepressants cannot be self-converted, combined or alternated from a shared use, name or milligram figure.
- Whether pharmacogenetic testing is needed is not the site's default conclusion. Lithium-related safety can also involve serum lithium, kidney function, thyroid, calcium, cardiac risk, age, pregnancy potential and the complete medicine list; the responsible team should interpret these clinical details.
- A similar mechanism, similar mood symptoms or prior lithium use cannot replace the current exact product, monitoring results and professional assessment; the site does not generate a continuation, stopping or switching conclusion from these clues.
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): U.S. public label for LITHOBID (lithium carbonate) 300 mg film-coated extended-release oral tablets (ANI Pharmaceuticals; effective 28 Oct 2022) ↗reviewed 2026-09-13
- FDA Orange Book data files: LITHOBID (lithium carbonate) NDA 018027, 300 mg extended-release oral-tablet RLD/RS product entry ↗reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
LITHOBIDlithium carbonate 300 mg extended release oral tablet
This page links to public primary-source material for LITHOBID. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Historical approval is recorded only as “prior to 1982”
The FDA Orange Book entry under NDA 018027 uses “Approved Prior to Jan 1, 1982”; the site does not invent a specific approval date from that field.
FDA Orange Book data files: LITHOBID (lithium carbonate) NDA 018027, 300 mg extended-release oral-tablet RLD/RS product entry ↗U.S. public-label effective version
The DailyMed label identifies ANI Pharmaceuticals and covers LITHOBID 300 mg extended-release oral tablets; it is a dated document, not live-supply evidence.
DailyMed (NLM): U.S. public label for LITHOBID (lithium carbonate) 300 mg film-coated extended-release oral tablets (ANI Pharmaceuticals; effective 28 Oct 2022) ↗
MARKET SCOPE
Market-record boundary
United States
Dated public label and Orange Book product recordThey support checking the U.S. brand, form, per-tablet amount, NDC and RLD/RS product fields; they do not establish today's stock, purchase availability, authenticity or individual suitability.
Markets outside the United States
Local brand, approval, pack and supply require item-by-item verificationNo status for Mainland China, the EU, Japan or another market is inferred from the U.S. LITHOBID label.
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.
RECORD FAQ
Record questions
Does 300 mg tell me how many tablets to take at once?
No. 300 mg is the labelled amount per tablet for this exact product. Individual tablet count, schedule, any catch-up and any adjustment must be decided by the responsible team using the prescription, serum-lithium monitoring, kidney function and the complete medicine list.
Can extended-release lithium carbonate be exchanged with an immediate-release tablet or lithium citrate liquid by milligrams?
Do not do this yourself. Their dosage forms, release characteristics and product identities differ; have the exact pack and prescription checked by a pharmacist or prescribing team.
What if an older adult develops tremor, unsteadiness, confusion or persistent vomiting/diarrhoea?
Do not use a webpage to decide stopping, catch-up or reduction. Contact local medical services promptly; severe altered awareness, fainting, abnormal heartbeat, breathing difficulty or inability to remain safe requires local emergency services immediately with every medicine pack.
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.