FDA Orange Book
Generic for Epivir
Epivir contains lamivudine. 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 Epivir is lamivudine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
Run it in Rivvi
Map Epivir 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.
Epivir products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 10MG/ML | Marketed (Rx) | AA | 3 | AA |
| tablet, oral | 150MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 300MG | Marketed (Rx) | AB | 7 | AB |
NDA 020596, 020564, held by VIIV HEALTHCARE CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lamivudine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 091606 | AB (A-rated, therapeutically equivalent) | December 2, 2011 | 150MG, 300MG |
| HETERO LABS LTD UNIT V | 203277 | AB (A-rated, therapeutically equivalent) | January 6, 2014 | 150MG, 300MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 203564 | AA (A-rated, therapeutically equivalent) | October 31, 2014 | 10MG/ML |
| AUROBINDO PHARMA LTD | 077695 | AA (A-rated, therapeutically equivalent) | November 21, 2016 | 10MG/ML |
| AUROBINDO PHARMA LTD | 077464 | AB (A-rated, therapeutically equivalent) | November 21, 2016 | 150MG, 300MG |
| SOMERSET THERAPEUTICS LLC | 206974 | AB (A-rated, therapeutically equivalent) | November 21, 2016 | 150MG, 300MG |
| CIPLA LTD | 077221 | AB (A-rated, therapeutically equivalent) | March 3, 2017 | 150MG, 300MG |
| STRIDES PHARMA GLOBAL PTE LTD | 090457 | AB (A-rated, therapeutically equivalent) | April 19, 2018 | 150MG, 300MG |
| MACLEODS PHARMACEUTICALS LTD | 090198 | AB (A-rated, therapeutically equivalent) | May 1, 2019 | 150MG, 300MG |
| HETERO LABS LTD UNIT III | 091475 | AA (A-rated, therapeutically equivalent) | October 6, 2023 | 10MG/ML |
Epivir NDC codes
Questions
Is there a generic for Epivir?
Yes. The generic name for Epivir is lamivudine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
What is the generic name for Epivir?
The active ingredient in Epivir is lamivudine, 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 Epivir and Lamivudine
- What is Lamivudine used for?FDA label uses
- Is Lamivudine a controlled substance?Federal schedule
- Generic for Epivir-hbvFDA Orange Book
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- NDC 49702-203Epivir NDC record
- NDC 49702-204Epivir NDC record
- NDC 49702-205Epivir NDC record