pyrazinamide

Generic: pyrazinamide tablet

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

Drug Facts

Product Profile

Brand Name pyrazinamide
Generic Name pyrazinamide tablet
Labeler marlex pharmaceuticals, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pyrazinamide 500 mg/1

Manufacturer
MARLEX PHARMACEUTICALS, INC

Identifiers & Regulatory

Product NDC 10135-735
Product ID 10135-735_45222685-8d74-a7e1-e063-6294a90a9945
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080157
Listing Expiration 2026-12-31
Marketing Start 2022-03-01

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135735
Hyphenated Format 10135-735

Supplemental Identifiers

RxCUI
198181
UNII
2KNI5N06TI
NUI
N0000175483

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 pyrazinamide (source: ndc)
Generic Name pyrazinamide tablet (source: ndc)
Application Number ANDA080157 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (10135-735-01)
  • 60 TABLET in 1 BOTTLE (10135-735-60)
  • 90 TABLET in 1 BOTTLE (10135-735-90)
source: ndc

Packages (3)

10135-735-01 100 TABLET in 1 BOTTLE (10135-735-01) 10135-735-60 60 TABLET in 1 BOTTLE (10135-735-60) 10135-735-90 90 TABLET in 1 BOTTLE (10135-735-90)

Ingredients (1)

pyrazinamide (500 mg/1)

Linked Drug Pages (1)

PYRAZINAMIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45222685-8d74-a7e1-e063-6294a90a9945", "openfda": {"nui": ["N0000175483"], "unii": ["2KNI5N06TI"], "rxcui": ["198181"], "spl_set_id": ["db250a85-2e20-87e9-e053-2a95a90a72b6"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["MARLEX PHARMACEUTICALS, INC"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10135-735-01)", "package_ndc": "10135-735-01", "marketing_start_date": "20220301"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (10135-735-60)", "package_ndc": "10135-735-60", "marketing_start_date": "20220301"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (10135-735-90)", "package_ndc": "10135-735-90", "marketing_start_date": "20220301"}], "brand_name": "PYRAZINAMIDE", "product_id": "10135-735_45222685-8d74-a7e1-e063-6294a90a9945", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "10135-735", "generic_name": "pyrazinamide tablet", "labeler_name": "MARLEX PHARMACEUTICALS, INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PYRAZINAMIDE", "active_ingredients": [{"name": "PYRAZINAMIDE", "strength": "500 mg/1"}], "application_number": "ANDA080157", "marketing_category": "ANDA", "marketing_start_date": "20220301", "listing_expiration_date": "20261231"}