isoniazid

Generic: isoniazid

Labeler: omnivium pharmaceuticals llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isoniazid
Generic Name isoniazid
Labeler omnivium pharmaceuticals llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isoniazid 300 mg/1

Manufacturer
OMNIVIUM PHARMACEUTICALS LLC.

Identifiers & Regulatory

Product NDC 81665-108
Product ID 81665-108_3966e8ed-31f4-6d0a-e063-6294a90a3233
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040090
Listing Expiration 2026-12-31
Marketing Start 2024-10-15

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81665108
Hyphenated Format 81665-108

Supplemental Identifiers

RxCUI
197832 311166
UPC
0381665108103 0381665108301 0381665107106 0381665108516
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 ANDA040090 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (81665-108-10)
  • 30 TABLET in 1 BOTTLE, PLASTIC (81665-108-30)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (81665-108-51)
source: ndc

Packages (3)

81665-108-10 100 TABLET in 1 BOTTLE, PLASTIC (81665-108-10) 81665-108-30 30 TABLET in 1 BOTTLE, PLASTIC (81665-108-30) 81665-108-51 1000 TABLET in 1 BOTTLE, PLASTIC (81665-108-51)

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": "3966e8ed-31f4-6d0a-e063-6294a90a3233", "openfda": {"nui": ["N0000175483"], "upc": ["0381665108103", "0381665108301", "0381665107106", "0381665108516"], "unii": ["V83O1VOZ8L"], "rxcui": ["197832", "311166"], "spl_set_id": ["35400f1d-fd25-4bfa-a382-ac390e21bf2e"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["OMNIVIUM PHARMACEUTICALS LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (81665-108-10)", "package_ndc": "81665-108-10", "marketing_start_date": "20241015"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (81665-108-30)", "package_ndc": "81665-108-30", "marketing_start_date": "20241015"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (81665-108-51)", "package_ndc": "81665-108-51", "marketing_start_date": "20241015"}], "brand_name": "isoniazid", "product_id": "81665-108_3966e8ed-31f4-6d0a-e063-6294a90a3233", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "81665-108", "generic_name": "isoniazid", "labeler_name": "OMNIVIUM PHARMACEUTICALS 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": "20241015", "listing_expiration_date": "20261231"}