rifabutin

Generic: rifabutin

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rifabutin
Generic Name rifabutin
Labeler ani pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

rifabutin 150 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-041
Product ID 70954-041_cc04157f-1cc1-4f4a-a77f-9042a99e7825
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215041
Listing Expiration 2026-12-31
Marketing Start 2021-12-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954041
Hyphenated Format 70954-041

Supplemental Identifiers

RxCUI
198200
UPC
0370954041108
UNII
1W306TDA6S
NUI
N0000175501 M0019113

Packaging Origin

Original Packager
true

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 ANDA215041 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (70954-041-10)
source: ndc

Packages (1)

70954-041-10 100 CAPSULE in 1 BOTTLE (70954-041-10)

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": "cc04157f-1cc1-4f4a-a77f-9042a99e7825", "openfda": {"nui": ["N0000175501", "M0019113"], "upc": ["0370954041108"], "unii": ["1W306TDA6S"], "rxcui": ["198200"], "spl_set_id": ["baf8ec98-bd0c-4b87-a7ee-813335431b89"], "pharm_class_cs": ["Rifamycins [CS]"], "pharm_class_epc": ["Rifamycin Antimycobacterial [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (70954-041-10)", "package_ndc": "70954-041-10", "marketing_start_date": "20211217"}], "brand_name": "Rifabutin", "product_id": "70954-041_cc04157f-1cc1-4f4a-a77f-9042a99e7825", "dosage_form": "CAPSULE", "pharm_class": ["Rifamycin Antimycobacterial [EPC]", "Rifamycins [CS]"], "product_ndc": "70954-041", "generic_name": "Rifabutin", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rifabutin", "active_ingredients": [{"name": "RIFABUTIN", "strength": "150 mg/1"}], "application_number": "ANDA215041", "marketing_category": "ANDA", "marketing_start_date": "20211217", "listing_expiration_date": "20261231"}