Medicine
Buspirone 5 mg tablet
Buspirone 5 mg tablet is a generic prescription medicine for oral use, made by 36 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Buspirone
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 154 more
- Manufacturers
- Zydus LifesciencesIndiaStrides PharmaIndiaAurobindo PharmaIndiaAvet PharmaceuticalsIndiaAccord HealthcareIndiaUnichem LaboratoriesIndiaEpic PharmaAdvagen PharmaAiPing PharmaceuticalApnar Pharma36 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N05BE01 Buspirone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 February 2002
- Identifiers
- RxCUI 866094, 866083, 866018 +2DailyMed set ID efa03f52-430e-455a-bdca-7f9d422b7b19, bee0edbf-3fc3-484b-9715-f13a329216ae, 37780596-3b6f-8d00-e063-6294a90ad4ad +37NDC 71610-203, 72162-1924, 72189-628 +37Application ANDA075022, ANDA075388, ANDA210907 +11
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
A sample of 40 packs from 36 labelers. The register lists 157 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 42543-741-06 | Strides PharmaIndia | 1 April 2021 |
| 500 tablet in 1 bottle | 42543-741-07 | Strides PharmaIndia | 1 April 2021 |
| 1000 tablet in 1 bottle | 42543-741-08 | Strides PharmaIndia | 1 April 2021 |
| 100 tablet in 1 bottle | 64380-741-06 | Strides PharmaIndia | 30 June 2015 |
| 500 tablet in 1 bottle | 64380-741-07 | Strides PharmaIndia | 30 June 2015 |
| 1000 tablet in 1 bottle | 64380-741-08 | Strides PharmaIndia | 30 June 2015 |
| 100 tablet in 1 bottle | 65841-781-01 | Zydus LifesciencesIndia | 3 May 2014 |
| 500 tablet in 1 bottle | 65841-781-05 | Zydus LifesciencesIndia | 3 May 2014 |
| 1000 tablet in 1 bottle | 65841-781-10 | Zydus LifesciencesIndia | 3 May 2014 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 65841-781-77 | Zydus LifesciencesIndia | 3 May 2014 |
| 100 tablet in 1 bottle | 68382-180-01 | Zydus LifesciencesIndia | 3 May 2014 |
| 500 tablet in 1 bottle | 68382-180-05 | Zydus LifesciencesIndia | 3 May 2014 |
| 1000 tablet in 1 bottle | 68382-180-10 | Zydus LifesciencesIndia | 3 May 2014 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 68382-180-77 | Zydus LifesciencesIndia | 3 May 2014 |
| 100 tablet in 1 bottle | 16729-200-01 | Accord HealthcareIndia | 15 December 2016 |
| 500 tablet in 1 bottle | 16729-200-16 | Accord HealthcareIndia | 15 December 2016 |
| 100 tablet in 1 bottle | 59651-389-01 | Aurobindo PharmaIndia | 21 February 2020 |
| 500 tablet in 1 bottle | 59651-389-05 | Aurobindo PharmaIndia | 21 February 2020 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 59651-389-10 | Aurobindo PharmaIndia | 21 February 2020 |
| 30 tablet in 1 bottle | 59651-389-30 | Aurobindo PharmaIndia | 21 February 2020 |
| 60 tablet in 1 bottle | 59651-389-60 | Aurobindo PharmaIndia | 21 February 2020 |
| 100 tablet in 1 bottle | 23155-023-01 | Avet PharmaceuticalsIndia | 18 September 2015 |
| 500 tablet in 1 bottle | 23155-023-05 | Avet PharmaceuticalsIndia | 20 September 2018 |
| 1000 tablet in 1 bottle | 23155-023-10 | Avet PharmaceuticalsIndia | 20 September 2018 |
| 100 tablet in 1 bottle, plastic | 29300-244-01 | Unichem LaboratoriesIndia | 20 November 2019 |
| 500 tablet in 1 bottle, plastic | 29300-244-05 | Unichem LaboratoriesIndia | 20 November 2019 |
| 100 tablet in 1 bottle | 42806-082-01 | Epic Pharma | 17 April 2019 |
| 500 tablet in 1 bottle | 42806-082-05 | Epic Pharma | 17 April 2019 |
| 100 tablet in 1 bottle | 42806-662-01 | Epic Pharma | 19 June 2020 |
| 500 tablet in 1 bottle | 42806-662-05 | Epic Pharma | 19 June 2020 |
| 100 tablet in 1 bottle | 72888-062-01 | Advagen Pharma | 29 December 2020 |
| 500 tablet in 1 bottle | 72888-062-05 | Advagen Pharma | 29 December 2020 |
| 100 tablet in 1 bottle | 11788-057-01 | AiPing Pharmaceutical | 26 September 2025 |
| 500 tablet in 1 bottle | 11788-057-05 | AiPing Pharmaceutical | 26 September 2025 |
| 100 tablet in 1 bottle | 24689-781-01 | Apnar Pharma | 17 June 2024 |
| 500 tablet in 1 bottle | 24689-781-05 | Apnar Pharma | 17 June 2024 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 51079-985-20 | Mylan Institutional | 25 March 2002 |
| 500 tablet in 1 bottle, plastic | 0378-1140-05 | Mylan Pharmaceuticals | 21 March 2002 |
| 100 tablet in 1 bottle | 69584-091-10 | Oxford Pharmaceuticals | 27 July 2020 |
| 500 tablet in 1 bottle | 69584-091-50 | Oxford Pharmaceuticals | 27 July 2020 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 29 September 1986 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Buspirone
Clinical summary
Buspirone is a prescription medicine indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. It is available as tablets and capsules for oral use. MedsAcross supplies Buspirone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about BuspironeFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Buspirone Hydrochloride prescribing information (Accord Healthcare) · U.S. National Library of Medicine, DailyMed
Need Buspirone 5 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.