FDA Orange Book
Is there a generic for Estring?
Estring 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 Estring (estradiol).
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Estring products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| insert, extended release, vaginal | 0.0075MG/24HR | Marketed (Rx) | None | 0 | None |
NDA 020472, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Estring NDC codes
Questions
Is there a generic for Estring?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Estring (estradiol).
What is the generic name for Estring?
The active ingredient in Estring 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 Estring and Estradiol
- What is Estring used for?FDA label uses
- Is Estring a controlled substance?Federal schedule
- What is Estradiol used for?FDA label uses
- Is Estradiol a controlled substance?Federal schedule
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