isoniazid

Generic: isoniazid

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isoniazid
Generic Name isoniazid
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isoniazid 300 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-978
Product ID 63187-978_5c1e5064-9311-4161-a11f-1e006dd97bfb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080937
Listing Expiration 2026-12-31
Marketing Start 1972-09-01

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187978
Hyphenated Format 63187-978

Supplemental Identifiers

RxCUI
197832
UNII
V83O1VOZ8L
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 isoniazid (source: ndc)
Generic Name isoniazid (source: ndc)
Application Number ANDA080937 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (63187-978-30)
  • 60 TABLET in 1 BOTTLE (63187-978-60)
  • 90 TABLET in 1 BOTTLE (63187-978-90)
source: ndc

Packages (3)

63187-978-30 30 TABLET in 1 BOTTLE (63187-978-30) 63187-978-60 60 TABLET in 1 BOTTLE (63187-978-60) 63187-978-90 90 TABLET in 1 BOTTLE (63187-978-90)

Ingredients (1)

isoniazid (300 mg/1)

Linked Drug Pages (1)

Isoniazid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5c1e5064-9311-4161-a11f-1e006dd97bfb", "openfda": {"nui": ["N0000175483"], "unii": ["V83O1VOZ8L"], "rxcui": ["197832"], "spl_set_id": ["65e50989-d24c-4bb3-a041-d6aea2635ef1"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-978-30)", "package_ndc": "63187-978-30", "marketing_start_date": "20180201"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-978-60)", "package_ndc": "63187-978-60", "marketing_start_date": "20180201"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63187-978-90)", "package_ndc": "63187-978-90", "marketing_start_date": "20180201"}], "brand_name": "Isoniazid", "product_id": "63187-978_5c1e5064-9311-4161-a11f-1e006dd97bfb", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "63187-978", "generic_name": "Isoniazid", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isoniazid", "active_ingredients": [{"name": "ISONIAZID", "strength": "300 mg/1"}], "application_number": "ANDA080937", "marketing_category": "ANDA", "marketing_start_date": "19720901", "listing_expiration_date": "20261231"}