FDA Orange Book
Generic for Retrovir
Retrovir contains zidovudine. 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 Retrovir is zidovudine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 3 of the 5 Retrovir products the Orange Book lists.
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Retrovir products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | AB | 2 | AB |
| injectable, injection | 10MG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 50MG/5ML | Marketed (Rx) | AA | 2 | AA |
| tablet, oral | 200MG | Discontinued | None | 0 | None |
| tablet, oral | 300MG | Discontinued | None | 3 | AB |
NDA 019655, 019951, 019910, 020518, 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 zidovudine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 077268 | AA (A-rated, therapeutically equivalent) | September 19, 2005 | 50MG/5ML |
| AUROBINDO PHARMA LTD | 077267 | AB (A-rated, therapeutically equivalent) | September 19, 2005 | 300MG |
| AUROBINDO PHARMA LTD INC | 078128 | AB (A-rated, therapeutically equivalent) | March 27, 2006 | 100MG |
| CIPLA LTD | 078349 | AB (A-rated, therapeutically equivalent) | May 23, 2007 | 100MG |
| HETERO LABS LTD UNIT III | 090092 | AB (A-rated, therapeutically equivalent) | April 25, 2008 | 300MG |
| CIPLA LTD | 077981 | AA (A-rated, therapeutically equivalent) | June 26, 2008 | 50MG/5ML |
| CIPLA LTD | 090561 | AB (A-rated, therapeutically equivalent) | October 27, 2010 | 300MG |
Retrovir NDC codes
Questions
Is there a generic for Retrovir?
Yes. The generic name for Retrovir is zidovudine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 3 of the 5 Retrovir products the Orange Book lists.
What is the generic name for Retrovir?
The active ingredient in Retrovir is zidovudine, 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.