isoniazid

Generic: isoniazid

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isoniazid
Generic Name isoniazid
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

isoniazid 300 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-709
Product ID 62135-709_2df7a936-6840-66cc-e063-6294a90ae096
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089776
Listing Expiration 2026-12-31
Marketing Start 1988-06-13

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135709
Hyphenated Format 62135-709

Supplemental Identifiers

RxCUI
197832
UPC
0362135709907
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 ANDA089776 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (62135-709-90)
source: ndc

Packages (1)

62135-709-90 90 TABLET in 1 BOTTLE (62135-709-90)

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": "2df7a936-6840-66cc-e063-6294a90ae096", "openfda": {"nui": ["N0000175483"], "upc": ["0362135709907"], "unii": ["V83O1VOZ8L"], "rxcui": ["197832"], "spl_set_id": ["2e09b1a5-9786-427f-bf00-be15b06eb7e7"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-709-90)", "package_ndc": "62135-709-90", "marketing_start_date": "20231020"}], "brand_name": "Isoniazid", "product_id": "62135-709_2df7a936-6840-66cc-e063-6294a90ae096", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "62135-709", "generic_name": "Isoniazid", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isoniazid", "active_ingredients": [{"name": "ISONIAZID", "strength": "300 mg/1"}], "application_number": "ANDA089776", "marketing_category": "ANDA", "marketing_start_date": "19880613", "listing_expiration_date": "20261231"}