FDA Orange Book
Generic for Rifadin
Rifadin contains rifampin. 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 Rifadin is rifampin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Rifadin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 150MG | Discontinued | None | 4 | AB |
| capsule, oral | 300MG | Discontinued | None | 4 | AB |
| injectable, injection | 600MG/VIAL | Marketed (Rx) | AP | 5 | AP |
NDA 050420, 050627, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic rifampin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| EPIC PHARMA LLC | 064150 | AB (A-rated, therapeutically equivalent) | January 2, 1998 | 150MG, 300MG |
| HIKMA PHARMACEUTICALS USA INC | 064217 | AP (A-rated, therapeutically equivalent) | October 29, 1999 | 600MG/VIAL |
| CHARTWELL MOLECULAR HOLDINGS LLC | 065390 | AB (A-rated, therapeutically equivalent) | March 28, 2008 | 150MG, 300MG |
| MYLAN LABORATORIES LTD | 065421 | AP (A-rated, therapeutically equivalent) | May 22, 2008 | 600MG/VIAL |
| EPIC PHARMA LLC | 065502 | AP (A-rated, therapeutically equivalent) | September 21, 2010 | 600MG/VIAL |
| LUPIN PHARMACEUTICALS INC | 090034 | AB (A-rated, therapeutically equivalent) | August 21, 2013 | 150MG, 300MG |
| FRESENIUS KABI USA LLC | 091181 | AP (A-rated, therapeutically equivalent) | August 21, 2014 | 600MG/VIAL |
| HIKMA PHARMACEUTICALS | 205039 | AP (A-rated, therapeutically equivalent) | March 3, 2016 | 600MG/VIAL |
| NOVITIUM PHARMA LLC | 219918 | AB (A-rated, therapeutically equivalent) | June 29, 2026 | 150MG, 300MG |
Questions
Is there a generic for Rifadin?
Yes. The generic name for Rifadin is rifampin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Rifadin?
The active ingredient in Rifadin is rifampin, 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.