FDA Orange Book
Generic for Emtriva
Emtriva contains emtricitabine. 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 Emtriva is emtricitabine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Emtriva products the Orange Book lists.
Run it in Rivvi
Map Emtriva and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Emtriva products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 200MG | Marketed (Rx) | AB | 2 | AB |
| solution, oral | 10MG/ML | Marketed (Rx) | None | 0 | None |
NDA 021500, 021896, held by GILEAD SCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic emtricitabine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CIPLA LTD | 091168 | AB (A-rated, therapeutically equivalent) | July 2, 2018 | 200MG |
| AUROBINDO PHARMA LTD | 079188 | AB (A-rated, therapeutically equivalent) | March 15, 2023 | 200MG |
Emtriva NDC codes
Questions
Is there a generic for Emtriva?
Yes. The generic name for Emtriva is emtricitabine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Emtriva products the Orange Book lists.
What is the generic name for Emtriva?
The active ingredient in Emtriva is emtricitabine, 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.