Medicine
Temazepam 22.5 mg capsule
Temazepam 22.5 mg capsule is a generic prescription medicine for oral use, made by 7 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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Temazepam
- Brand
- Sold under the generic name
- Strength
- 22.5 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 30 capsules, 100 capsules, 500 capsules and 16 more
- Manufacturers
- Ascend LaboratoriesIndiaAlembic PharmaceuticalsIndiaAsclemedAmneal PharmaceuticalsBryant Ranch PrepackSolco HealthcareSpecGx
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIV
- ATC code
- N05CD07 Temazepam
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 February 2010
- Identifiers
- RxCUI 198241, 198242, 198243 +1DailyMed set ID 93b1be7f-ec41-46bb-a258-56cb459e2c92, 1e37d59b-b8be-46ef-8706-fffd563a8c15, c9bc61b4-a579-4003-98da-b6f6e381c150 +7NDC 62332-381, 63629-8604, 0406-9959 +7Application ANDA211542, ANDA071457, NDA018163 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 capsule in 1 bottle | 46708-381-30 | Alembic PharmaceuticalsIndia | 27 November 2018 |
| 30 capsule in 1 bottle | 62332-381-30 | Alembic PharmaceuticalsIndia | 27 November 2018 |
| 100 capsule in 1 bottle | 67877-149-01 | Ascend LaboratoriesIndia | 28 June 2012 |
| 500 capsule in 1 bottle | 67877-149-05 | Ascend LaboratoriesIndia | 28 June 2012 |
| 30 capsule in 1 bottle | 67877-149-30 | Ascend LaboratoriesIndia | 28 June 2012 |
| 30 capsule in 1 bottle | 65162-584-03 | Amneal Pharmaceuticals | 23 May 2016 |
| 100 capsule in 1 bottle | 65162-584-10 | Amneal Pharmaceuticals | 23 May 2016 |
| 1000 capsule in 1 bottle | 65162-584-11 | Amneal Pharmaceuticals | 23 May 2016 |
| 500 capsule in 1 bottle | 65162-584-50 | Amneal Pharmaceuticals | 23 May 2016 |
| 30 capsule in 1 bottle, plastic | 43547-613-03 | Solco Healthcare | 5 January 2023 |
| 30 capsule in 1 bottle | 0406-9959-03 | SpecGx | 23 February 2010 |
| 30 capsule in 1 bottle | 63629-8604-1 | Bryant Ranch Prepack | 13 July 2021 |
| 30 capsule in 1 bottle | 71335-2043-1 | Bryant Ranch Prepack | 10 February 2022 |
| 30 capsule in 1 bottle | 72162-1827-3 | Bryant Ranch Prepack | 7 March 2024 |
| 100 capsule in 1 bottle | 76420-474-01 | Asclemed | 18 September 2025 |
| 500 capsule in 1 bottle | 76420-474-05 | Asclemed | 18 September 2025 |
| 30 capsule in 1 bottle | 76420-474-30 | Asclemed | 18 September 2025 |
| 60 capsule in 1 bottle | 76420-474-60 | Asclemed | 18 September 2025 |
| 90 capsule in 1 bottle | 76420-474-90 | Asclemed | 18 September 2025 |
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 27 February 1981 | 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 Temazepam 22.5 mg capsule.
Other strengths and forms of Temazepam
Clinical summary
Temazepam is a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days). It is available as capsules for oral use. MedsAcross supplies Temazepam 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 TemazepamFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- RESTORIL prescribing information (SpecGx) · U.S. National Library of Medicine, DailyMed
Need Temazepam 22.5 mg capsule 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.