isoniazid

Generic: isoniazid

Labeler: mylan institutional inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isoniazid
Generic Name isoniazid
Labeler mylan institutional inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isoniazid 300 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-083
Product ID 51079-083_2c63f06e-644c-83aa-e063-6394a90a879a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080937
Marketing Start 1994-06-09
Marketing End 2026-11-30

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51079083
Hyphenated Format 51079-083

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
  • 100 BLISTER PACK in 1 CARTON (51079-083-20) / 1 TABLET in 1 BLISTER PACK (51079-083-01)
source: ndc

Packages (1)

51079-083-20 100 BLISTER PACK in 1 CARTON (51079-083-20) / 1 TABLET in 1 BLISTER PACK (51079-083-01)

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": "2c63f06e-644c-83aa-e063-6394a90a879a", "openfda": {"nui": ["N0000175483"], "unii": ["V83O1VOZ8L"], "rxcui": ["197832"], "spl_set_id": ["60a6b514-fa7f-4bc7-85b0-e5a14fa56b59"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (51079-083-20)  / 1 TABLET in 1 BLISTER PACK (51079-083-01)", "package_ndc": "51079-083-20", "marketing_end_date": "20261130", "marketing_start_date": "19940609"}], "brand_name": "Isoniazid", "product_id": "51079-083_2c63f06e-644c-83aa-e063-6394a90a879a", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "51079-083", "generic_name": "Isoniazid", "labeler_name": "Mylan Institutional Inc.", "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": "20261130", "marketing_start_date": "19940609"}