FDA Orange Book · active-ingredient family
Rifampin
Rifampin: 3 brands, 12 generics; first approved May 25, 1989; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
12
Listed patents
0
Presentations
21
Brand (NDA) products
Originator applications
- SANOFI AVENTIS USNDA 0506271989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/VIAL INJECTABLE INJECTION Rx AP - RIFADINRLDSANOFI AVENTIS USNDA 050420—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — - OXFORD PHARMSNDA 050429—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Rx AB
Generic (ANDA) products (12)
Abbreviated applications
- RIFAMPINNOVITIUM PHARMAANDA 21991820262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - RIFAMPINHIKMA PHARMSANDA 2050392016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/VIAL INJECTABLE INJECTION Rx AP - RIFAMPINWATSON PHARMS TEVAANDA 2067362016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/VIAL INJECTABLE INJECTION Discontinued — - RIFAMPINFRESENIUS KABI USAANDA 0911812014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/VIAL INJECTABLE INJECTION Rx AP - RIFAMPINAVET LIFESCIENCESANDA 2041012014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/VIAL INJECTABLE INJECTION Discontinued — - RIFAMPINLUPIN PHARMSANDA 09003420132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - RIFAMPINEPIC PHARMA LLCANDA 0655022010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/VIAL INJECTABLE INJECTION Rx AP - RIFAMPINMYLAN LABS LTDANDA 0654212008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/VIAL INJECTABLE INJECTION Rx AP - RIFAMPINCHARTWELL MOLECULARANDA 06539020082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - RIFAMPINHIKMAANDA 06502820012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - RIFAMPINHIKMAANDA 0642171999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/VIAL INJECTABLE INJECTION Rx AP - RIFAMPINEPIC PHARMA LLCANDA 06415019982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
37 yr 9 mo ago
Most recent approval
1 mo ago
Approvals span 1989–2026 across 15 FDA applications.
Brand (NDA) 320%
Generic (ANDA) 1280%
Rifampin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
