isoniazid

Generic: isoniazid

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

Drug Facts

Product Profile

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

isoniazid 300 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-0071
Product ID 0555-0071_ead93989-8a7e-4483-917e-388152515e1d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080937
Marketing Start 1972-09-01
Marketing End 2027-06-30

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05550071
Hyphenated Format 0555-0071

Supplemental Identifiers

RxCUI
197832 311166
UPC
0305550066026
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 ANDA080937 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, UNIT-DOSE (0555-0071-01)
  • 100 TABLET in 1 BOTTLE (0555-0071-02)
source: ndc

Packages (2)

0555-0071-01 30 TABLET in 1 BOTTLE, UNIT-DOSE (0555-0071-01) 0555-0071-02 100 TABLET in 1 BOTTLE (0555-0071-02)

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": "ead93989-8a7e-4483-917e-388152515e1d", "openfda": {"nui": ["N0000175483"], "upc": ["0305550066026"], "unii": ["V83O1VOZ8L"], "rxcui": ["197832", "311166"], "spl_set_id": ["9499f1cf-2f46-4047-8b71-90aee7dee854"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, UNIT-DOSE (0555-0071-01)", "package_ndc": "0555-0071-01", "marketing_end_date": "20270331", "marketing_start_date": "19720901"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (0555-0071-02)", "package_ndc": "0555-0071-02", "marketing_end_date": "20270630", "marketing_start_date": "19720901"}], "brand_name": "Isoniazid", "product_id": "0555-0071_ead93989-8a7e-4483-917e-388152515e1d", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "0555-0071", "generic_name": "Isoniazid", "labeler_name": "Teva Pharmaceuticals USA, 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": "20270630", "marketing_start_date": "19720901"}