Home NDC 60687-198 Rifabutin
Product NDC 60687-198
11-digit product format 606870198
Labeler code 60687
Product ID 60687-198_9f7b9f44-e86d-1574-e053-2a95a90a8223
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rifabutin
Dosage form CAPSULE
Route ORAL
Labeler American Health Packaging
Application ANDA090033
Marketing category ANDA
Marketing start 2016-06-08
Marketing end 2021-01-31
Substance RIFABUTIN
Active strength 150 mg/1
Pharmacologic classes Rifamycin Antimycobacterial [EPC],Rifamycins [CS]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090033-001 RIFABUTIN RIFABUTIN 150MG CAPSULE / ORAL 2014-02-24
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A090033-001 RIFABUTIN 150MG CAPSULE / ORAL 2014-02-24 a50c72e98297…