Drug
Who makes temazepam?
21 companies list temazepam as a human prescription drug, including under the names RESTORIL. Forms: capsule. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing temazepam
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | capsule | ANDAANDA071456, ANDA071457, ANDA071620 | 21 | 1 |
| Alembic Pharmaceuticals LimitedIndia | capsule | ANDAANDA211542 | 8 | 7 |
| SpecGx LLCUnited States | capsule | NDANDA018163 | 8 | 5 |
| Aphena Pharma Solutions - Tennessee, LLC | capsule | ANDA, NDAANDA071456, ANDA071457, ANDA071638 | 8 | 0 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | capsule | ANDAANDA071456, ANDA071457 | 4 | 1 |
| Amneal Ireland LimitedIreland | capsule | ANDAANDA203482 | 4 | 1 |
| Proficient Rx LPUnited States | capsule | ANDAANDA071456, ANDA071457 | 4 | 1 |
| ASCEND Therapeutics US, LLC | capsule | ANDAANDA071456, ANDA071457 | 4 | 0 |
| Solco healthcare U.S., LLC | capsule | ANDAANDA201781 | 4 | 0 |
| PD-Rx Pharmaceuticals Inc.United States | capsule | ANDA, NDAANDA071456, ANDA071457, NDA018163 | 3 | 1 |
| Preferred Pharmaceuticals Inc.United States | capsule | ANDAANDA071456, ANDA071457, ANDA211542 | 3 | 1 |
| Amneal Pharmaceuticals of New York, LLCIndia | capsule | ANDAANDA203482 | 2 | 14 |
| International Medication Systems, Ltd.United States | capsule | ANDAANDA071456, ANDA071457 | 2 | 3 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | capsule | ANDAANDA071456 | 2 | 1 |
| Actavis LLCUnited States | capsule | ANDAANDA071620 | 2 | 1 |
| Golden State Medical Supply Inc.United States | capsule | ANDAANDA211542 | 2 | 1 |
| RemedyRepack, IncUnited States | capsule | ANDAANDA071456, ANDA071620 | 2 | 1 |
| AvPAK | capsule | ANDAANDA071456, ANDA071457 | 2 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule | NDANDA018163 | 1 | 5 |
| NuCare Pharmaceuticals,Inc.United States | capsule | ANDAANDA071457 | 1 | 1 |
| MAJOR Pharmaceuticals Inc. | capsule | ANDAANDA071457 | 1 | 0 |
Bulk ingredient listings
- FIS FABBRICA ITALIANA SINTETICI SPAItaly · 2 NDC
- CAMBREX PROFARMACO MILANO SRLItaly · 1 NDC
- R.L.Fine Chem Private LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes temazepam?
- 21 companies list temazepam as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Alembic Pharmaceuticals Limited, SpecGx LLC, Aphena Pharma Solutions - Tennessee, LLC, ASCLEMED USA INC. DBA ENOVACHEM. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic RESTORIL?
- 19 companies list temazepam under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies temazepam active ingredient?
- 3 companies list temazepam as a bulk ingredient, including FIS FABBRICA ITALIANA SINTETICI SPA, CAMBREX PROFARMACO MILANO SRL, R.L.Fine Chem Private Limited.