FDA Orange Book
Generic for Tyblume
Tyblume contains levonorgestrel and ethinyl 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
Yes. The generic name for Tyblume is levonorgestrel and ethinyl estradiol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB3.
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Tyblume products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.02MG;0.1MG | Marketed (Rx) | None | 2 | AB3 |
NDA 209405, held by EXELTIS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levonorgestrel and ethinyl estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| XIROMED PHARMA ESPANA SL | 214640 | AB3 (A-rated, therapeutically equivalent) | August 16, 2023 | 0.02MG;0.1MG |
| LUPIN LTD | 217087 | AB3 (A-rated, therapeutically equivalent) | February 15, 2024 | 0.02MG;0.1MG |
Questions
Is there a generic for Tyblume?
Yes. The generic name for Tyblume is levonorgestrel and ethinyl estradiol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB3.
What is the generic name for Tyblume?
The active ingredient in Tyblume is levonorgestrel and ethinyl 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.