pyrazinamide

Generic: pyrazinamide

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

Drug Facts

Product Profile

Brand Name pyrazinamide
Generic Name pyrazinamide
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pyrazinamide 500 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-484
Product ID 70954-484_e043f21d-4a30-4d23-bc03-12207af7d6d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080157
Listing Expiration 2027-12-31
Marketing Start 2021-05-11

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954484
Hyphenated Format 70954-484

Supplemental Identifiers

RxCUI
198181
UPC
0370954484103 0370954484301 0370954484202
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 ANDA080157 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (70954-484-10)
  • 90 TABLET in 1 BOTTLE (70954-484-20)
  • 100 TABLET in 1 BOTTLE (70954-484-30)
source: ndc

Packages (3)

70954-484-10 60 TABLET in 1 BOTTLE (70954-484-10) 70954-484-20 90 TABLET in 1 BOTTLE (70954-484-20) 70954-484-30 100 TABLET in 1 BOTTLE (70954-484-30)

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": "e043f21d-4a30-4d23-bc03-12207af7d6d7", "openfda": {"nui": ["N0000175483"], "upc": ["0370954484103", "0370954484301", "0370954484202"], "unii": ["2KNI5N06TI"], "rxcui": ["198181"], "spl_set_id": ["262d8829-728c-48db-b89b-88d13b87e684"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (70954-484-10)", "package_ndc": "70954-484-10", "marketing_start_date": "20210511"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (70954-484-20)", "package_ndc": "70954-484-20", "marketing_start_date": "20210511"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-484-30)", "package_ndc": "70954-484-30", "marketing_start_date": "20210511"}], "brand_name": "Pyrazinamide", "product_id": "70954-484_e043f21d-4a30-4d23-bc03-12207af7d6d7", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "70954-484", "generic_name": "Pyrazinamide", "labeler_name": "ANI 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": "20210511", "listing_expiration_date": "20271231"}