FDA Orange Book
Generic for Naprosyn
Naprosyn contains naproxen. 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 Naprosyn is naproxen. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Naprosyn and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Naprosyn products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 25MG/ML | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 250MG | Discontinued | None | 8 | AB |
| tablet, oral | 375MG | Discontinued | None | 8 | AB |
| tablet, oral | 500MG | Marketed (Rx) | AB | 8 | AB |
NDA 018965, 017581, held by ATNAHS PHARMA US LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic naproxen
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GRANULES INDIA LTD | 074140 | AB (A-rated, therapeutically equivalent) | December 21, 1993 | 250MG, 375MG, 500MG |
| TEVA PHARMACEUTICALS USA INC | 074201 | AB (A-rated, therapeutically equivalent) | December 21, 1993 | 250MG, 375MG, 500MG |
| HIKMA PHARMACEUTICALS USA INC | 074190 | AB (A-rated, therapeutically equivalent) | March 30, 1994 | 25MG/ML |
| AMNEAL PHARMACEUTICALS NY LLC | 075927 | AB (A-rated, therapeutically equivalent) | December 18, 2001 | 250MG, 375MG, 500MG |
| GLENMARK PHARMACEUTICALS LTD | 078250 | AB (A-rated, therapeutically equivalent) | March 28, 2007 | 250MG, 375MG, 500MG |
| ZYDUS PHARMACEUTICALS USA INC | 078620 | AB (A-rated, therapeutically equivalent) | June 7, 2007 | 250MG, 375MG, 500MG |
| PHARMAZONE | 091416 | AB (A-rated, therapeutically equivalent) | February 14, 2011 | 250MG, 375MG, 500MG |
| AUROBINDO PHARMA LTD | 200429 | AB (A-rated, therapeutically equivalent) | November 8, 2011 | 250MG, 375MG, 500MG |
| SCIEGEN PHARMACEUTICALS INC | 212517 | AB (A-rated, therapeutically equivalent) | February 21, 2020 | 250MG, 375MG, 500MG |
| AMNEAL PHARMACEUTICALS LLC | 212705 | AB (A-rated, therapeutically equivalent) | July 31, 2020 | 25MG/ML |
| NOVITIUM PHARMA LLC | 211910 | AB (A-rated, therapeutically equivalent) | March 10, 2021 | 25MG/ML |
| HETERO LABS LTD UNIT III | 215776 | AB (A-rated, therapeutically equivalent) | June 7, 2022 | 25MG/ML |
Naprosyn NDC codes
Questions
Is there a generic for Naprosyn?
Yes. The generic name for Naprosyn is naproxen. 12 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 Naprosyn?
The active ingredient in Naprosyn is naproxen, 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.