FDA Orange Book
Generic for Xanax
Xanax 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 Xanax is alprazolam. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Xanax products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.25MG | Marketed (Rx) | AB | 6 | AB |
| tablet, oral | 0.5MG | Marketed (Rx) | AB | 6 | AB |
| tablet, oral | 1MG | Marketed (Rx) | AB | 6 | AB |
| tablet, oral | 2MG | Marketed (Rx) | AB | 6 | AB |
NDA 018276, held by UPJOHN US 2 LLC. 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 |
|---|---|---|---|---|
| NOVITIUM PHARMA LLC | 074174 | AB (A-rated, therapeutically equivalent) | October 19, 1993 | 0.25MG, 0.5MG, 1MG, 2MG |
| ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 074342 | AB (A-rated, therapeutically equivalent) | October 31, 1993 | 0.25MG, 0.5MG, 1MG, 2MG |
| SANDOZ INC | 074112 | AB (A-rated, therapeutically equivalent) | December 29, 1995 | 0.25MG, 0.5MG, 1MG |
| SANDOZ INC | 074909 | AB (A-rated, therapeutically equivalent) | March 25, 1998 | 2MG |
| NATCO PHARMA LTD | 200739 | AB (A-rated, therapeutically equivalent) | April 15, 2015 | 0.25MG, 0.5MG, 1MG, 2MG |
| AUROBINDO PHARMA LTD | 203346 | AB (A-rated, therapeutically equivalent) | July 31, 2015 | 0.25MG, 0.5MG, 1MG, 2MG |
| UNICHEM LABORATORIES LTD | 213204 | AB (A-rated, therapeutically equivalent) | July 13, 2026 | 0.25MG, 0.5MG, 1MG, 2MG |
Xanax NDC codes
Questions
Is there a generic for Xanax?
Yes. The generic name for Xanax is alprazolam. 6 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 Xanax?
The active ingredient in Xanax 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.
More on Xanax and Alprazolam
- What is Xanax used for?FDA label uses
- Is Xanax a controlled substance?Schedule IV
- What is Alprazolam used for?FDA label uses
- Is Alprazolam a controlled substance?Schedule IV
- Generic for Xanax XRFDA Orange Book
- Generic for NiravamFDA Orange Book
- Benzodiazepines listFDA drug class
- NDC 0009-0029Xanax NDC record
- NDC 0009-0090Xanax NDC record
- NDC 0009-0094Xanax NDC record
- Schedule IV drugs listDEA schedule