FDA Orange Book
Generic for Cytotec
Cytotec contains 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 Cytotec is misoprostol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Cytotec products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.1MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 0.2MG | Marketed (Rx) | AB | 2 | AB |
NDA 019268, 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 misoprostol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ANI PHARMACEUTICALS INC | 076095 | AB (A-rated, therapeutically equivalent) | July 10, 2002 | 0.1MG, 0.2MG |
| ACQ PHARMA LLC | 210201 | AB (A-rated, therapeutically equivalent) | July 2, 2019 | 0.1MG, 0.2MG |
Cytotec NDC codes
Questions
Is there a generic for Cytotec?
Yes. The generic name for Cytotec is misoprostol. 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 Cytotec?
The active ingredient in Cytotec is 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.