FDA Orange Book
Generic for Arthrotec
Arthrotec contains diclofenac and misoprostol. 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 Arthrotec is diclofenac and misoprostol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Arthrotec products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, delayed release, oral | 50MG;0.2MG | Marketed (Rx) | AB | 4 | AB |
| tablet, delayed release, oral | 75MG;0.2MG | Marketed (Rx) | AB | 4 | AB |
NDA 020607, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic diclofenac and misoprostol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC | 201089 | AB (A-rated, therapeutically equivalent) | July 9, 2012 | 50MG;0.2MG, 75MG;0.2MG |
| AMNEAL PHARMACEUTICALS | 203995 | AB (A-rated, therapeutically equivalent) | November 25, 2016 | 50MG;0.2MG, 75MG;0.2MG |
| YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD | 205143 | AB (A-rated, therapeutically equivalent) | February 19, 2020 | 50MG;0.2MG, 75MG;0.2MG |
| MICRO LABS LTD | 204355 | AB (A-rated, therapeutically equivalent) | July 15, 2021 | 50MG;0.2MG, 75MG;0.2MG |
Arthrotec NDC codes
Questions
Is there a generic for Arthrotec?
Yes. The generic name for Arthrotec is diclofenac and misoprostol. 4 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 Arthrotec?
The active ingredient in Arthrotec is diclofenac and misoprostol, 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.