PACK CHECK · MARKET FIRST

BuSparGeneric namebuspirone hydrochloride

Reading size

How this medicine works

The historical label says the exact mechanism is unknown and describes high in-vitro affinity for 5-HT1A receptors. Receptor findings do not predict an individual response.

Read source: United States ↗Historical public record · reviewed 2026-09-09More 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
BuSpar
Generic name
buspirone hydrochloride
Dosage-form class
Dosage form and presentation as documented in the linked primary label
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 pack is

BuSpar is the brand name in this record; buspirone hydrochloride is the generic name. Read both together with the dosage form (exact dosage form to be checked from the current pack).

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.

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.

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 · Historical FDA brand label, Nov 2010, page 19

5 mg buspirone hydrochloride per tablet; 100 tablets/bottle (2010 historical record)

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 0087-0818-41
Form and route
Buspirone hydrochloride oral tablets (historical brand) · Oral (historical product-identity field)
Listing review
Cited product evidence reviewed 2026-09-09; actual marketing, stock and availability are not established.
buspirone hydrochloride
5 mgLabelled amount per tablet, not an individual tablet count
Package
100 tablets per bottle
Open the presentation source ↗Historical public record · reviewed 2026-09-09

United States label · Historical FDA brand label, Nov 2010, page 19

10 mg buspirone hydrochloride per tablet; 100 tablets/bottle (2010 historical record)

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 0087-0819-41
Form and route
Buspirone hydrochloride oral tablets (historical brand) · Oral (historical product-identity field)
Listing review
Cited product evidence reviewed 2026-09-09; actual marketing, stock and availability are not established.
buspirone hydrochloride
10 mgLabelled amount per tablet, not an individual tablet count
Package
100 tablets per bottle
Open the presentation source ↗Historical public record · reviewed 2026-09-09

United States label · Historical FDA brand label, Nov 2010, page 19

15 mg buspirone hydrochloride per tablet; 60 tablets/bottle (2010 historical record)

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 0087-0822-32
Form and route
Buspirone hydrochloride oral tablets (historical brand) · Oral (historical product-identity field)
Listing review
Cited product evidence reviewed 2026-09-09; actual marketing, stock and availability are not established.
buspirone hydrochloride
15 mgLabelled amount per tablet, not an individual tablet count
Package
60 tablets per bottle
Open the presentation source ↗Historical public record · reviewed 2026-09-09

United States label · Historical FDA brand label, Nov 2010, page 19

15 mg buspirone hydrochloride per tablet; 180 tablets/bottle (2010 historical record)

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 0087-0822-33
Form and route
Buspirone hydrochloride oral tablets (historical brand) · Oral (historical product-identity field)
Listing review
Cited product evidence reviewed 2026-09-09; actual marketing, stock and availability are not established.
buspirone hydrochloride
15 mgLabelled amount per tablet, not an individual tablet count
Package
180 tablets per bottle
Open the presentation source ↗Historical public record · reviewed 2026-09-09

United States label · Historical FDA brand label, Nov 2010, page 19

30 mg buspirone hydrochloride per tablet; 60 tablets/bottle (2010 historical record)

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 0087-0824-81
Form and route
Buspirone hydrochloride oral tablets (historical brand) · Oral (historical product-identity field)
Listing review
Cited product evidence reviewed 2026-09-09; actual marketing, stock and availability are not established.
buspirone hydrochloride
30 mgLabelled amount per tablet, not an individual tablet count
Package
60 tablets per bottle
Open the presentation source ↗Historical public record · reviewed 2026-09-09

PACKAGE-VISUAL STATUS

Historical label text only; no verified originator pack image

Originator packaging and splitting diagrams have not completed visual review. Rising Pharma generic panels must not stand in for BuSpar; similar appearance cannot authenticate a product.

Open the visual-withholding verification source ↗

Open this record's official electronic leaflet ↗

LABEL READING · NOT A PRESCRIPTION

Buspirone label reading: start with the whole medicine list

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.

These safety notes use the distinct Rising Pharma generic label, not an updated BuSpar brand label. The historical brand PDF is listed separately. Check the actual manufacturer, strength and label date with a pharmacist.

  • Include antidepressants, triptans and linezolid in the medicine list. MAOI contraindications and serotonin-syndrome warnings require clinician-managed treatment changes.
  • Severe confusion, high fever, rigidity or seizures require urgent medical help; a webpage cannot diagnose serotonin syndrome.
  • Some older adults may be more sensitive. Dizziness, unsteadiness or drowsiness warrants fall/driving precautions and clinical review; severe liver or kidney impairment needs professional assessment.
  • Mg describes strength per tablet; 60 Tablets is the bottle count. Check the actual label before interpreting scores or different figures; do not calculate a personal regimen here.
Open this record's official electronic leaflet ↗

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

  1. Brand and generic nameBoth must match the medicine named by the record.
  2. Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
  3. Market and notice dateA record applies only to the country or region and date it names.
  4. Lot, pack and manufacturerRecord these only when the official notice specifically names them.
  5. 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 · 2026-09-09

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 · 3

This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.

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.

No dated, product-scoped official safety record is currently listed in this directory

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 BuSpar (buspirone hydrochloride). Keep the exact pack, its current label and the full medicine list together.

  1. Identify the exact product

    BuSpar is the brand in this record and buspirone hydrochloride is the active-ingredient name. Check both with the dosage form (Dosage form and presentation as documented in the linked primary label) and the market on the actual pack.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

HOW IT WORKS · NOT A TREATMENT PLAN

How does it differ from common sedatives?

  • Different action: the historical label distinguishes buspirone from benzodiazepines and does not attribute anticonvulsant or muscle-relaxant effects to it. A similar use does not mean the same medicine.
  • Before a switch: buspirone does not prevent benzodiazepine withdrawal; do not abruptly stop an existing sedative or sleeping medicine because of it.
  • Keep the food pattern consistent: food affects absorption. The historical label calls for consistent use with food or without food; check the current label for the actual product with a pharmacist rather than alternating.
Open the primary pharmacology source ↗

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.

SOURCE-TRACEABLE ARCHIVE

BuSparbuspirone hydrochloride

This page links to public primary-source material for BuSpar. 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

  1. Initial U.S. approval

    FDA approved the original application as a new molecular entity.

    FDA Drugs@FDA: BuSpar / buspirone hydrochloride, NDA 018731, historical discontinued RLD tablets ↗
  2. Historical brand labeling supplement

    The S-051 label lists five bottle presentations and patient instructions for the specific DIVIDOSE tablets.

    FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted ↗

MARKET SCOPE

Market-record boundary

United States

Four listed historical brand strengths discontinued

FDA lists 5, 10, 15 and 30 mg as discontinued RLDs, not RS, with a determination that withdrawal was not for safety or effectiveness.

Mainland China

Current market record not established

No Chinese brand, approval, strength, supply or interchangeability is inferred from U.S. records.

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.

CDE listed-drug directory ↗ NMPA public query ↗

RECORD FAQ

Record questions

Does a score mean I can split it myself?

Check the exact product and prescription. The 2010 label describes halves for specific 5/10 mg tablets and halves or thirds for specific 15/30 mg DIVIDOSE tablets, not every manufacturer or an individual regimen.

Why might another label list 7.5 mg?

A generic product may have different strengths. The NDA 018731 brand table here lists 5, 10, 15 and 30 mg; a generic 7.5 mg product must not be inserted into it.

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.

EDITORIAL RECORD

Who prepared and checked this page

Byline
OriginDrug Content Editorial
Review role
Public primary-source verification
Last reviewed
2026-09-09
Source record
3 clickable primary-source entry points are listed with this dossier.

The review role checks source traceability, stated market, document version and product-identity fields. It is not a claim of clinical licensure, prescribing authority or individual pharmacy service. Read the editorial policy.

Search records
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