pyrazinamide

Generic: pyrazinamide

Labeler: hikma pharmaceuticals usa inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pyrazinamide
Generic Name pyrazinamide
Labeler hikma pharmaceuticals usa inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pyrazinamide 500 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc

Identifiers & Regulatory

Product NDC 0054-0812
Product ID 0054-0812_05eb3847-557f-460c-951f-e614fb9f9045
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA081319
Listing Expiration 2026-12-31
Marketing Start 2024-08-30

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540812
Hyphenated Format 0054-0812

Supplemental Identifiers

RxCUI
198181
UPC
0300540812218
UNII
2KNI5N06TI
NUI
N0000175483

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 pyrazinamide (source: ndc)
Generic Name pyrazinamide (source: ndc)
Application Number ANDA081319 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 CONTAINER (0054-0812-21)
  • 90 TABLET in 1 CONTAINER (0054-0812-22)
  • 100 TABLET in 1 CONTAINER (0054-0812-25)
  • 500 TABLET in 1 CONTAINER (0054-0812-29)
source: ndc

Packages (4)

0054-0812-21 60 TABLET in 1 CONTAINER (0054-0812-21) 0054-0812-22 90 TABLET in 1 CONTAINER (0054-0812-22) 0054-0812-25 100 TABLET in 1 CONTAINER (0054-0812-25) 0054-0812-29 500 TABLET in 1 CONTAINER (0054-0812-29)

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": "05eb3847-557f-460c-951f-e614fb9f9045", "openfda": {"nui": ["N0000175483"], "upc": ["0300540812218"], "unii": ["2KNI5N06TI"], "rxcui": ["198181"], "spl_set_id": ["566db230-3d73-482f-b67d-defd0b2dc46c"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 CONTAINER (0054-0812-21)", "package_ndc": "0054-0812-21", "marketing_start_date": "20240830"}, {"sample": false, "description": "90 TABLET in 1 CONTAINER (0054-0812-22)", "package_ndc": "0054-0812-22", "marketing_start_date": "20240830"}, {"sample": false, "description": "100 TABLET in 1 CONTAINER (0054-0812-25)", "package_ndc": "0054-0812-25", "marketing_start_date": "20240830"}, {"sample": false, "description": "500 TABLET in 1 CONTAINER (0054-0812-29)", "package_ndc": "0054-0812-29", "marketing_start_date": "20240830"}], "brand_name": "pyrazinamide", "product_id": "0054-0812_05eb3847-557f-460c-951f-e614fb9f9045", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "0054-0812", "generic_name": "pyrazinamide", "labeler_name": "Hikma Pharmaceuticals USA Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "pyrazinamide", "active_ingredients": [{"name": "PYRAZINAMIDE", "strength": "500 mg/1"}], "application_number": "ANDA081319", "marketing_category": "ANDA", "marketing_start_date": "20240830", "listing_expiration_date": "20261231"}