rifabutin

Generic: rifabutin

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

Drug Facts

Product Profile

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

rifabutin 150 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-738
Product ID 10135-738_43e1cc33-400c-6f7d-e063-6394a90ab38d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215041
Listing Expiration 2026-12-31
Marketing Start 2022-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135738
Hyphenated Format 10135-738

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 ANDA215041 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (10135-738-01)
source: ndc

Packages (1)

10135-738-01 100 CAPSULE in 1 BOTTLE (10135-738-01)

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": "43e1cc33-400c-6f7d-e063-6394a90ab38d", "openfda": {"nui": ["N0000175501", "M0019113"], "unii": ["1W306TDA6S"], "rxcui": ["198200"], "spl_set_id": ["df7d4103-42e4-4e4f-e053-2a95a90a8ce8"], "pharm_class_cs": ["Rifamycins [CS]"], "pharm_class_epc": ["Rifamycin Antimycobacterial [EPC]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (10135-738-01)", "package_ndc": "10135-738-01", "marketing_start_date": "20220501"}], "brand_name": "Rifabutin", "product_id": "10135-738_43e1cc33-400c-6f7d-e063-6394a90ab38d", "dosage_form": "CAPSULE", "pharm_class": ["Rifamycin Antimycobacterial [EPC]", "Rifamycins [CS]"], "product_ndc": "10135-738", "generic_name": "Rifabutin", "labeler_name": "Marlex 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": "20220501", "listing_expiration_date": "20261231"}