FDA Orange Book
Generic for Diastat
Diastat contains diazepam. 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 Diastat is diazepam. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Diastat products the Orange Book lists.
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Diastat products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, rectal | 10MG/2ML (5MG/ML) | Discontinued | None | 2 | AB |
| gel, rectal | 15MG/3ML (5MG/ML) | Discontinued | None | 0 | None |
| gel, rectal | 2.5MG/0.5ML (5MG/ML) | Marketed (Rx) | AB | 1 | AB |
| gel, rectal | 20MG/4ML (5MG/ML) | Discontinued | None | 2 | AB |
| gel, rectal | 5MG/ML (5MG/ML) | Discontinued | None | 0 | None |
NDA 020648, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic diazepam
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVEL LABORATORIES INC | 091076 | AB (A-rated, therapeutically equivalent) | May 30, 2023 | 10MG/2ML (5MG/ML), 20MG/4ML (5MG/ML) |
| NAVINTA LLC | 217468 | AB (A-rated, therapeutically equivalent) | November 14, 2025 | 10MG/2ML (5MG/ML), 2.5MG/0.5ML (5MG/ML), 20MG/4ML (5MG/ML) |
Diastat NDC codes
Questions
Is there a generic for Diastat?
Yes. The generic name for Diastat is diazepam. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Diastat products the Orange Book lists.
What is the generic name for Diastat?
The active ingredient in Diastat is diazepam, 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.