isoniazid

Generic: isoniazid

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

Drug Facts

Product Profile

Brand Name isoniazid
Generic Name isoniazid
Labeler marlex pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isoniazid 100 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-804
Product ID 10135-804_3e871908-abb7-9d35-e063-6394a90ac63d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040090
Listing Expiration 2026-12-31
Marketing Start 2025-03-01

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135804
Hyphenated Format 10135-804

Supplemental Identifiers

RxCUI
197832 311166
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
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (10135-804-01)
source: ndc

Packages (1)

10135-804-01 100 TABLET in 1 BOTTLE, PLASTIC (10135-804-01)

Ingredients (1)

isoniazid (100 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": "3e871908-abb7-9d35-e063-6394a90ac63d", "openfda": {"nui": ["N0000175483"], "unii": ["V83O1VOZ8L"], "rxcui": ["197832", "311166"], "spl_set_id": ["312cd403-b211-64ef-e063-6394a90aab88"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (10135-804-01)", "package_ndc": "10135-804-01", "marketing_start_date": "20250301"}], "brand_name": "isoniazid", "product_id": "10135-804_3e871908-abb7-9d35-e063-6394a90ac63d", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "10135-804", "generic_name": "isoniazid", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "isoniazid", "active_ingredients": [{"name": "ISONIAZID", "strength": "100 mg/1"}], "application_number": "ANDA040090", "marketing_category": "ANDA", "marketing_start_date": "20250301", "listing_expiration_date": "20261231"}