isoniazid

Generic: isoniazid

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isoniazid
Generic Name isoniazid
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isoniazid 300 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2800
Product ID 71335-2800_b2662f53-4b10-4d41-b868-3515e50d9956
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 713352800
Hyphenated Format 71335-2800

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 (71335-2800-1)
  • 30 TABLET in 1 BOTTLE (71335-2800-2)
  • 60 TABLET in 1 BOTTLE (71335-2800-3)
  • 35 TABLET in 1 BOTTLE (71335-2800-4)
  • 90 TABLET in 1 BOTTLE (71335-2800-5)
source: ndc

Packages (5)

71335-2800-1 100 TABLET in 1 BOTTLE (71335-2800-1) 71335-2800-2 30 TABLET in 1 BOTTLE (71335-2800-2) 71335-2800-3 60 TABLET in 1 BOTTLE (71335-2800-3) 71335-2800-4 35 TABLET in 1 BOTTLE (71335-2800-4) 71335-2800-5 90 TABLET in 1 BOTTLE (71335-2800-5)

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": "b2662f53-4b10-4d41-b868-3515e50d9956", "openfda": {"nui": ["N0000175483"], "unii": ["V83O1VOZ8L"], "rxcui": ["197832"], "spl_set_id": ["b6d6dccc-2577-4bbb-896e-5f75b65ee6ca"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (71335-2800-1)", "package_ndc": "71335-2800-1", "marketing_end_date": "20280228", "marketing_start_date": "20251013"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-2800-2)", "package_ndc": "71335-2800-2", "marketing_end_date": "20280228", "marketing_start_date": "20251013"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-2800-3)", "package_ndc": "71335-2800-3", "marketing_end_date": "20280228", "marketing_start_date": "20251013"}, {"sample": false, "description": "35 TABLET in 1 BOTTLE (71335-2800-4)", "package_ndc": "71335-2800-4", "marketing_end_date": "20280228", "marketing_start_date": "20251013"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-2800-5)", "package_ndc": "71335-2800-5", "marketing_end_date": "20280228", "marketing_start_date": "20251013"}], "brand_name": "Isoniazid", "product_id": "71335-2800_b2662f53-4b10-4d41-b868-3515e50d9956", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "71335-2800", "generic_name": "isoniazid", "labeler_name": "Bryant Ranch Prepack", "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"}