Medicine
Diazepam 5 mg tablet
Diazepam 5 mg tablet is a generic prescription medicine for oral use, made by 22 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)
- Diazepam
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 116 more
- Manufacturers
- Aurobindo PharmaIndiaBryant Ranch PrepackNuCare Pharmaceuticals,IncSunrise PharmaceuticalTeva PharmaceuticalsMylan PharmaceuticalsChartwell RXMylan Institutional22 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
- Schedule CIV
- ATC code
- N05BA01 Diazepam
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 September 1985
- Identifiers
- RxCUI 197591, 197589, 197590DailyMed set ID 5114ae6e-8cae-e96f-e063-6294a90a9e60, 823093aa-d0cd-53c9-e053-2a91aa0a5235, 2483426d-3782-432a-8b8d-86c06ef0de4a +26NDC 67046-0943, 68071-4770, 43063-970 +26Application ANDA071321, ANDA070325, ANDA070303 +2
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 22 labelers. The register lists 119 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 59651-653-01 | Aurobindo PharmaIndia | 14 December 2023 |
| 500 tablet in 1 bottle | 59651-653-05 | Aurobindo PharmaIndia | 14 December 2023 |
| 1000 tablet in 1 bottle | 59651-653-99 | Aurobindo PharmaIndia | 14 December 2023 |
| 90 tablet in 1 bottle | 62135-787-90 | Chartwell RX | 1 May 2024 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 51079-285-20 | Mylan Institutional | 4 November 1997 |
| 100 tablet in 1 bottle, plastic | 0378-0345-01 | Mylan Pharmaceuticals | 4 September 1985 |
| 500 tablet in 1 bottle, plastic | 0378-0345-05 | Mylan Pharmaceuticals | 4 September 1985 |
| 100 tablet in 1 bottle | 11534-203-01 | Sunrise Pharmaceutical | 10 December 2024 |
| 1000 tablet in 1 bottle | 11534-203-03 | Sunrise Pharmaceutical | 10 December 2024 |
| 500 tablet in 1 bottle | 11534-203-04 | Sunrise Pharmaceutical | 10 December 2024 |
| 100 tablet in 1 bottle | 0172-3926-60 | Teva Pharmaceuticals | 10 December 1986 |
| 500 tablet in 1 bottle | 0172-3926-70 | Teva Pharmaceuticals | 10 December 1986 |
| 1000 tablet in 1 bottle | 0172-3926-80 | Teva Pharmaceuticals | 10 December 1986 |
| 10 tablet in 1 bottle | 68071-3682-1 | NuCare Pharmaceuticals | 6 September 2024 |
| 6 tablet in 1 bottle | 68071-3682-6 | NuCare Pharmaceuticals | 6 September 2024 |
| 10 tablet in 1 bottle | 68071-3686-1 | NuCare Pharmaceuticals | 18 September 2024 |
| 30 tablet in 1 bottle | 68071-3686-3 | NuCare Pharmaceuticals | 18 September 2024 |
| 10 tablet in 1 bottle | 68071-4770-1 | NuCare Pharmaceuticals,Inc | 18 February 2019 |
| 30 tablet in 1 bottle | 68071-4770-3 | NuCare Pharmaceuticals,Inc | 18 February 2019 |
| 15 tablet in 1 bottle | 68071-4770-5 | NuCare Pharmaceuticals,Inc | 18 February 2019 |
| 90 tablet in 1 bottle | 68071-4770-9 | NuCare Pharmaceuticals,Inc | 18 February 2019 |
| 10 tablet in 1 bottle | 68071-4922-1 | NuCare Pharmaceuticals,Inc | 13 June 2019 |
| 8 tablet in 1 bottle | 68071-4922-4 | NuCare Pharmaceuticals,Inc | 13 June 2019 |
| 6 tablet in 1 bottle | 68071-4922-6 | NuCare Pharmaceuticals,Inc | 13 June 2019 |
| 120 tablet in 1 bottle | 63629-1523-0 | Bryant Ranch Prepack | 18 January 2012 |
| 12 tablet in 1 bottle | 63629-1523-1 | Bryant Ranch Prepack | 4 October 2005 |
| 15 tablet in 1 bottle | 63629-1523-2 | Bryant Ranch Prepack | 9 April 2007 |
| 20 tablet in 1 bottle | 63629-1523-3 | Bryant Ranch Prepack | 16 November 2005 |
| 30 tablet in 1 bottle | 63629-1523-4 | Bryant Ranch Prepack | 6 April 2006 |
| 60 tablet in 1 bottle | 63629-1523-5 | Bryant Ranch Prepack | 2 February 2006 |
| 90 tablet in 1 bottle | 63629-1523-6 | Bryant Ranch Prepack | 6 June 2006 |
| 10 tablet in 1 bottle | 63629-1523-7 | Bryant Ranch Prepack | 23 October 2007 |
| 1 tablet in 1 bottle | 63629-1523-9 | Bryant Ranch Prepack | 23 July 2008 |
| 120 tablet in 1 bottle | 71335-1584-0 | Bryant Ranch Prepack | 10 February 2022 |
| 12 tablet in 1 bottle | 71335-1584-1 | Bryant Ranch Prepack | 10 February 2022 |
| 15 tablet in 1 bottle | 71335-1584-2 | Bryant Ranch Prepack | 10 February 2022 |
| 20 tablet in 1 bottle | 71335-1584-3 | Bryant Ranch Prepack | 10 February 2022 |
| 30 tablet in 1 bottle | 71335-1584-4 | Bryant Ranch Prepack | 10 February 2022 |
| 60 tablet in 1 bottle | 71335-1584-5 | Bryant Ranch Prepack | 10 February 2022 |
| 90 tablet in 1 bottle | 71335-1584-6 | Bryant Ranch Prepack | 10 February 2022 |
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 15 November 1963 | 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
Alternatives
Other makers and brands of Diazepam 5 mg tablet.
Other strengths and forms of Diazepam
Clinical summary
Diazepam is a benzodiazepine indicated for the treatment of anxiety disorders Short-term treatment of anxiety symptoms Treatment of tremor, acute agitation, among other approved uses. MedsAcross supplies Diazepam 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 DiazepamFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Valium prescribing information (Waylis Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Diazepam 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.