isoniazid

Generic: isoniazid

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isoniazid
Generic Name isoniazid
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isoniazid 300 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1617
Product ID 67046-1617_44592907-10af-c357-e063-6394a90a2751
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040090
Listing Expiration 2026-12-31
Marketing Start 2025-11-24

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461617
Hyphenated Format 67046-1617

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 ANDA040090 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1617-3)
source: ndc

Packages (1)

67046-1617-3 30 TABLET in 1 BLISTER PACK (67046-1617-3)

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": "44592907-10af-c357-e063-6394a90a2751", "openfda": {"nui": ["N0000175483"], "unii": ["V83O1VOZ8L"], "rxcui": ["197832"], "spl_set_id": ["44592c5c-d11c-148d-e063-6294a90ab35c"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1617-3)", "package_ndc": "67046-1617-3", "marketing_start_date": "20251124"}], "brand_name": "isoniazid", "product_id": "67046-1617_44592907-10af-c357-e063-6394a90a2751", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "67046-1617", "generic_name": "isoniazid", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "isoniazid", "active_ingredients": [{"name": "ISONIAZID", "strength": "300 mg/1"}], "application_number": "ANDA040090", "marketing_category": "ANDA", "marketing_start_date": "20251124", "listing_expiration_date": "20261231"}