isoniazid

Generic: isoniazid

Labeler: genus lifesciences
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isoniazid
Generic Name isoniazid
Labeler genus lifesciences
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isoniazid 300 mg/1

Manufacturer
Genus Lifesciences

Identifiers & Regulatory

Product NDC 64950-217
Product ID 64950-217_6ea58bc8-a5a8-47a1-81e1-f769924e1502
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080937
Marketing Start 2024-11-01
Marketing End 2028-02-28

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64950217
Hyphenated Format 64950-217

Supplemental Identifiers

RxCUI
197832 311166
UPC
0364950217100 0364950216103
UNII
V83O1VOZ8L
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 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 (64950-217-03)
  • 100 TABLET in 1 BOTTLE (64950-217-10)
source: ndc

Packages (2)

64950-217-03 30 TABLET in 1 BOTTLE (64950-217-03) 64950-217-10 100 TABLET in 1 BOTTLE (64950-217-10)

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": "6ea58bc8-a5a8-47a1-81e1-f769924e1502", "openfda": {"nui": ["N0000175483"], "upc": ["0364950217100", "0364950216103"], "unii": ["V83O1VOZ8L"], "rxcui": ["197832", "311166"], "spl_set_id": ["f0b46d1d-2300-457d-a7bd-a88a3f8d2235"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["Genus Lifesciences"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (64950-217-03)", "package_ndc": "64950-217-03", "marketing_end_date": "20271231", "marketing_start_date": "20241101"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (64950-217-10)", "package_ndc": "64950-217-10", "marketing_end_date": "20280228", "marketing_start_date": "20241101"}], "brand_name": "Isoniazid", "product_id": "64950-217_6ea58bc8-a5a8-47a1-81e1-f769924e1502", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "64950-217", "generic_name": "isoniazid", "labeler_name": "Genus Lifesciences", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isoniazid", "active_ingredients": [{"name": "ISONIAZID", "strength": "300 mg/1"}], "application_number": "ANDA080937", "marketing_category": "ANDA", "marketing_end_date": "20280228", "marketing_start_date": "20241101"}