FDA Orange Book
Is there a generic for Elestrin?
Elestrin contains estradiol. 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 Elestrin (estradiol).
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Elestrin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, metered, transdermal | 0.06% (0.87GM/ACTIVATION) | Marketed (Rx) | None | 0 | None |
NDA 021813, held by VIATRIS SPECIALTY LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Elestrin NDC codes
Questions
Is there a generic for Elestrin?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Elestrin (estradiol).
What is the generic name for Elestrin?
The active ingredient in Elestrin is estradiol, 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.
More on Elestrin and Estradiol
- What is Estradiol used for?FDA label uses
- Is Estradiol a controlled substance?Federal schedule
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- Estrogens listFDA drug class
- Elestrin Medicare Part D coverageBy plan and state
- NDC 0037-4801Elestrin NDC record