Medicine
Diazepam 10 mg/2 mL gel
Diazepam 10 mg/2 mL gel is a generic prescription medicine for rectal use, made by 3 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°C to 25°C (68°F to 77°F), Excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Diazepam
- Brand
- Sold under the generic name
- Strength
- 10 mg/2 mL
- Dosage form
- Gel
- Route
- Rectal
- Packs
- 2 syringes and 6 more
- Manufacturers
- Zydus LifesciencesIndiaNavintaOceanside Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), Excursions permitted between 15°C and 30°C (59°F and 86°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
- 29 July 1997
- Identifiers
- RxCUI 801957, 801961, 801966DailyMed set ID b5b17a28-2cab-4c0d-8f9d-7b224e4d0989, b1b2848b-b265-4f6f-9141-bf106dec0726, 652714c7-25c4-4d05-979d-8eee3b6f2f4dNDC 68475-802, 68682-652, 68475-803 +6Application ANDA217468, NDA020648
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 2 syringe, plastic in 1 package / .5 mL in 1 syringe, plastic | 70710-2078-2 | Zydus LifesciencesIndia | 15 December 2025 |
| 2 syringe, plastic in 1 package / 2 mL in 1 syringe, plastic | 70710-2079-2 | Zydus LifesciencesIndia | 15 December 2025 |
| 2 syringe, plastic in 1 package / 4 mL in 1 syringe, plastic | 70710-2080-2 | Zydus LifesciencesIndia | 15 December 2025 |
| 2 syringe, plastic in 1 package / .5 mL in 1 syringe, plastic | 68475-802-02 | Navinta | 6 February 2026 |
| 2 syringe, plastic in 1 package / 2 mL in 1 syringe, plastic | 68475-803-02 | Navinta | 6 February 2026 |
| 2 syringe, plastic in 1 package / 4 mL in 1 syringe, plastic | 68475-804-02 | Navinta | 6 February 2026 |
| 2 syringe, plastic in 1 package / .5 mL in 1 syringe, plastic | 68682-650-20 | Oceanside Pharmaceuticals | 29 July 1997 |
| 2 syringe, plastic in 1 package / 2 mL in 1 syringe, plastic | 68682-652-20 | Oceanside Pharmaceuticals | 29 July 1997 |
| 2 syringe, plastic in 1 package / 4 mL in 1 syringe, plastic | 68682-655-20 | Oceanside Pharmaceuticals | 29 July 1997 |
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
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 10 mg/2 mL gel 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.