FDA Orange Book
Is there a generic for Crinone?
Crinone contains progesterone. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Crinone (progesterone).
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Crinone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, vaginal | 4% | Discontinued | None | 0 | None |
| gel, vaginal | 8% | Marketed (Rx) | None | 0 | None |
NDA 020701, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Crinone NDC codes
Questions
Is there a generic for Crinone?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Crinone (progesterone).
What is the generic name for Crinone?
The active ingredient in Crinone is progesterone, 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.