Home NDC 59762-1350-1 Rifabutin
Product NDC 59762-1350
Requested package NDC 59762-1350-1
11-digit product format 597621350
Labeler code 59762
Product ID 59762-1350_25e74b16-cdf0-4959-be62-1745c4e4cf0a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rifabutin
Dosage form CAPSULE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA050689
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-04-07
Substance RIFABUTIN
Active strength 150 mg/1
Pharmacologic classes Rifamycin Antimycobacterial [EPC], Rifamycins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 N050689-001 MYCOBUTIN RIFABUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050689-001 AB
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 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N050689-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Rifabutin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIFABUTIN 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1W306TDA6S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198200 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59762-1350-1 Rifabutin 100 in 1 BOTTLE CAPSULE 100 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-1350 RIFABUTIN CAPSULE [MYLAN PHARMACEUTICALS INC.] 12 Current NDC, Legacy NDC, 1 package rows 20250523_c2026b67-4755-4236-96b6-a6b5e7399707.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59762-1350-1 59762135001 100 CAPSULE in 1 BOTTLE (59762-1350-1) 100 capsule 2014-04-07 0000-00-00 No No Current