isoniazid

Generic: isoniazid

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

Drug Facts

Product Profile

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

isoniazid 300 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-9405
Product ID 68788-9405_3015cc07-8b51-4018-845f-99bad1b9fab8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080937
Marketing Start 2014-11-03
Marketing End 2026-07-01

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687889405
Hyphenated Format 68788-9405

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 TABLET in 1 BOTTLE (68788-9405-1)
  • 30 TABLET in 1 BOTTLE (68788-9405-3)
  • 60 TABLET in 1 BOTTLE (68788-9405-6)
  • 90 TABLET in 1 BOTTLE (68788-9405-9)
source: ndc

Packages (4)

68788-9405-1 100 TABLET in 1 BOTTLE (68788-9405-1) 68788-9405-3 30 TABLET in 1 BOTTLE (68788-9405-3) 68788-9405-6 60 TABLET in 1 BOTTLE (68788-9405-6) 68788-9405-9 90 TABLET in 1 BOTTLE (68788-9405-9)

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": "3015cc07-8b51-4018-845f-99bad1b9fab8", "openfda": {"nui": ["N0000175483"], "unii": ["V83O1VOZ8L"], "rxcui": ["197832"], "spl_set_id": ["e199dbfa-6d79-4c20-9984-9cd0c1907510"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-9405-1)", "package_ndc": "68788-9405-1", "marketing_end_date": "20260701", "marketing_start_date": "20141103"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-9405-3)", "package_ndc": "68788-9405-3", "marketing_end_date": "20260701", "marketing_start_date": "20141103"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-9405-6)", "package_ndc": "68788-9405-6", "marketing_end_date": "20260701", "marketing_start_date": "20141103"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-9405-9)", "package_ndc": "68788-9405-9", "marketing_end_date": "20260701", "marketing_start_date": "20141103"}], "brand_name": "Isoniazid", "product_id": "68788-9405_3015cc07-8b51-4018-845f-99bad1b9fab8", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "68788-9405", "generic_name": "Isoniazid", "labeler_name": "Preferred Pharmaceuticals, 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": "20260701", "marketing_start_date": "20141103"}