Home NDC 70518-4594 Rifabutin
Product NDC 70518-4594
11-digit product format 705184594
Labeler code 70518
Product ID 70518-4594_4dc43e85-741c-b323-e063-6394a90a0d75
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rifabutin
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA215041
Marketing category ANDA
Marketing start 2026-03-24
Substance RIFABUTIN
Active strength 150 mg/1
Pharmacologic classes Rifamycin Antimycobacterial [EPC], Rifamycins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 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 70518-4594-0 Rifabutin 60 in 1 BOTTLE, PLASTIC CAPSULE 60 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4594-0 70518459400 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-4594-0) 60 capsule 2026-03-24 No No Current 70518-4594-1 70518459401 50 POUCH in 1 BOX (70518-4594-1) / 1 CAPSULE in 1 POUCH (70518-4594-2) 50 pouch 2026-06-05 0 Current