FDA Orange Book
Generic for Diastat Acudial
Diastat Acudial 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 Acudial is diazepam. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Diastat Acudial products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, rectal | 10MG/2ML (5MG/ML) | Marketed (Rx) | AB | 2 | AB |
| gel, rectal | 20MG/4ML (5MG/ML) | Marketed (Rx) | AB | 2 | AB |
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), 20MG/4ML (5MG/ML) |
Diastat Acudial NDC codes
Questions
Is there a generic for Diastat Acudial?
Yes. The generic name for Diastat Acudial is diazepam. 2 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 Diastat Acudial?
The active ingredient in Diastat Acudial 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.