FDA Orange Book
Generic for Ec-naprosyn
Ec-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 Ec-naprosyn is naproxen. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ec-naprosyn products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, delayed release, oral | 375MG | Marketed (Rx) | AB | 5 | AB |
| tablet, delayed release, oral | 500MG | Marketed (Rx) | AB | 5 | AB |
NDA 020067, 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 |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 075227 | AB (A-rated, therapeutically equivalent) | June 30, 1998 | 375MG, 500MG |
| AUROBINDO PHARMA USA INC | 075390 | AB (A-rated, therapeutically equivalent) | April 19, 2001 | 375MG, 500MG |
| NUVO PHAMACEUTICALS INC | 091432 | AB (A-rated, therapeutically equivalent) | September 19, 2011 | 375MG, 500MG |
| TP ANDA HOLDINGS LLC | 216908 | AB (A-rated, therapeutically equivalent) | May 31, 2023 | 375MG, 500MG |
| NOVITIUM PHARMA LLC | 218497 | AB (A-rated, therapeutically equivalent) | June 12, 2024 | 375MG, 500MG |
Ec-naprosyn NDC codes
Questions
Is there a generic for Ec-naprosyn?
Yes. The generic name for Ec-naprosyn is naproxen. 5 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 Ec-naprosyn?
The active ingredient in Ec-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.