rifabutin

Generic: rifabutin

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

Drug Facts

Product Profile

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

rifabutin 150 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-1350
Product ID 59762-1350_25e74b16-cdf0-4959-be62-1745c4e4cf0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050689
Listing Expiration 2026-12-31
Marketing Start 2014-04-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 597621350
Hyphenated Format 59762-1350

Supplemental Identifiers

RxCUI
198200
UPC
0359762135018
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 NDA050689 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (59762-1350-1)
source: ndc

Packages (1)

59762-1350-1 100 CAPSULE in 1 BOTTLE (59762-1350-1)

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": "25e74b16-cdf0-4959-be62-1745c4e4cf0a", "openfda": {"nui": ["N0000175501", "M0019113"], "upc": ["0359762135018"], "unii": ["1W306TDA6S"], "rxcui": ["198200"], "spl_set_id": ["c2026b67-4755-4236-96b6-a6b5e7399707"], "pharm_class_cs": ["Rifamycins [CS]"], "pharm_class_epc": ["Rifamycin Antimycobacterial [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (59762-1350-1)", "package_ndc": "59762-1350-1", "marketing_start_date": "20140407"}], "brand_name": "Rifabutin", "product_id": "59762-1350_25e74b16-cdf0-4959-be62-1745c4e4cf0a", "dosage_form": "CAPSULE", "pharm_class": ["Rifamycin Antimycobacterial [EPC]", "Rifamycins [CS]"], "product_ndc": "59762-1350", "generic_name": "rifabutin", "labeler_name": "Mylan Pharmaceuticals 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": "20140407", "listing_expiration_date": "20261231"}