FDA Orange Book
Generic for Niravam
Niravam contains alprazolam. 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 Niravam is alprazolam. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Niravam products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, orally disintegrating, oral | 0.25MG | Discontinued | None | 2 | AB |
| tablet, orally disintegrating, oral | 0.5MG | Discontinued | None | 2 | AB |
| tablet, orally disintegrating, oral | 1MG | Discontinued | None | 2 | AB |
| tablet, orally disintegrating, oral | 2MG | Discontinued | None | 2 | AB |
NDA 021726, held by UCB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic alprazolam
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 078088 | AB (A-rated, therapeutically equivalent) | January 9, 2009 | 0.25MG, 0.5MG, 1MG, 2MG |
| ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 078561 | AB (A-rated, therapeutically equivalent) | March 16, 2010 | 0.25MG, 0.5MG, 1MG, 2MG |
Questions
Is there a generic for Niravam?
Yes. The generic name for Niravam is alprazolam. 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 Niravam?
The active ingredient in Niravam is alprazolam, 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.