FDA Orange Book
Generic for Restoril
Restoril contains temazepam. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Restoril is temazepam. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Restoril products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 15MG | Marketed (Rx) | AB | 7 | AB |
| capsule, oral | 22.5MG | Marketed (Rx) | AB | 5 | AB |
| capsule, oral | 30MG | Marketed (Rx) | AB | 7 | AB |
| capsule, oral | 7.5MG | Marketed (Rx) | AB | 5 | AB |
NDA 018163, held by SPECGX LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic temazepam
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVEL LABORATORIES INC | 071456 | AB (A-rated, therapeutically equivalent) | April 21, 1987 | 15MG |
| ACTAVIS ELIZABETH LLC | 071620 | AB (A-rated, therapeutically equivalent) | August 7, 1987 | 15MG, 30MG |
| CHARTWELL RX SCIENCES LLC | 071427 | AB (A-rated, therapeutically equivalent) | January 12, 1988 | 15MG |
| CHARTWELL RX SCIENCES LLC | 071428 | AB (A-rated, therapeutically equivalent) | January 12, 1988 | 30MG |
| NOVEL LABORATORIES INC | 071457 | AB (A-rated, therapeutically equivalent) | June 22, 2012 | 22.5MG, 30MG, 7.5MG |
| PRINSTON PHARMACEUTICAL INC | 201781 | AB (A-rated, therapeutically equivalent) | June 4, 2015 | 15MG, 22.5MG, 30MG, 7.5MG |
| AMNEAL PHARMACEUTICALS | 203482 | AB (A-rated, therapeutically equivalent) | May 23, 2016 | 15MG, 22.5MG, 30MG, 7.5MG |
| ALEMBIC PHARMACEUTICALS LTD | 211542 | AB (A-rated, therapeutically equivalent) | November 23, 2018 | 15MG, 22.5MG, 30MG, 7.5MG |
| ALKEM LABORATORIES LTD | 217875 | AB (A-rated, therapeutically equivalent) | August 24, 2023 | 15MG, 22.5MG, 30MG, 7.5MG |
Restoril NDC codes
Questions
Is there a generic for Restoril?
Yes. The generic name for Restoril is temazepam. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Restoril?
The active ingredient in Restoril is temazepam, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Restoril and Temazepam
- What is Restoril used for?FDA label uses
- Is Restoril a controlled substance?Schedule IV
- What is Temazepam used for?FDA label uses
- Is Temazepam a controlled substance?Schedule IV
- Benzodiazepines listFDA drug class
- NDC 0406-9914Restoril NDC record
- NDC 0406-9915Restoril NDC record
- NDC 0406-9916Restoril NDC record
- Schedule IV drugs listDEA schedule