rifabutin

Generic: rifabutin

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name rifabutin
Generic Name rifabutin
Labeler remedyrepack inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

rifabutin 150 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4254
Product ID 70518-4254_40089d1e-2431-3042-e063-6394a90afb4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050689
Listing Expiration 2026-12-31
Marketing Start 2025-01-13

Pharmacologic Class

Established (EPC)
rifamycin antimycobacterial [epc]
Chemical Structure
rifamycins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184254
Hyphenated Format 70518-4254

Supplemental Identifiers

RxCUI
198200
UNII
1W306TDA6S
NUI
N0000175501 M0019113

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name rifabutin (source: ndc)
Generic Name rifabutin (source: ndc)
Application Number NDA050689 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-4254-0)
source: ndc

Packages (1)

70518-4254-0 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-4254-0)

Ingredients (1)

rifabutin (150 mg/1)

Linked Drug Pages (1)

Rifabutin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40089d1e-2431-3042-e063-6394a90afb4a", "openfda": {"nui": ["N0000175501", "M0019113"], "unii": ["1W306TDA6S"], "rxcui": ["198200"], "spl_set_id": ["25a60937-cbbe-4a50-994f-2ce15203f589"], "pharm_class_cs": ["Rifamycins [CS]"], "pharm_class_epc": ["Rifamycin Antimycobacterial [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (70518-4254-0)", "package_ndc": "70518-4254-0", "marketing_start_date": "20250113"}], "brand_name": "Rifabutin", "product_id": "70518-4254_40089d1e-2431-3042-e063-6394a90afb4a", "dosage_form": "CAPSULE", "pharm_class": ["Rifamycin Antimycobacterial [EPC]", "Rifamycins [CS]"], "product_ndc": "70518-4254", "generic_name": "rifabutin", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rifabutin", "active_ingredients": [{"name": "RIFABUTIN", "strength": "150 mg/1"}], "application_number": "NDA050689", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20250113", "listing_expiration_date": "20261231"}