Home NDC 10135-738 Rifabutin
Product NDC 10135-738
11-digit product format 101350738
Labeler code 10135
Product ID 10135-738_43e1cc33-400c-6f7d-e063-6394a90ab38d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rifabutin
Dosage form CAPSULE
Route ORAL
Labeler Marlex Pharmaceuticals, Inc.
Application ANDA215041
Marketing category ANDA
Marketing start 2022-05-01
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 A215041-001 RIFABUTIN RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215041-001 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 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 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 A215041-001 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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Rifabutin
Listing expiration 2026-12-31 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 10135-738-01 Rifabutin 100 in 1 BOTTLE CAPSULE 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-738 RIFABUTIN CAPSULE [MARLEX PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20241018_df7d4103-42e4-4e4f-e053-2a95a90a8ce8.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 10135-738-01 10135073801 100 CAPSULE in 1 BOTTLE (10135-738-01) 100 capsule 2022-05-01 0000-00-00 No No Current