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 SOLUTION
Routes
ORAL
Active Ingredients

isoniazid 50 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-550
Product ID 62135-550_44fdc5f6-d8fc-49a1-e063-6394a90ad33c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA081118
Listing Expiration 2026-12-31
Marketing Start 1997-07-21

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135550
Hyphenated Format 62135-550

Supplemental Identifiers

RxCUI
105292
UPC
0362135550479
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 ANDA081118 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (62135-550-47)
source: ndc

Packages (1)

62135-550-47 473 mL in 1 BOTTLE (62135-550-47)

Ingredients (1)

isoniazid (50 mg/5mL)

Linked Drug Pages (1)

Isoniazid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44fdc5f6-d8fc-49a1-e063-6394a90ad33c", "openfda": {"nui": ["N0000175483"], "upc": ["0362135550479"], "unii": ["V83O1VOZ8L"], "rxcui": ["105292"], "spl_set_id": ["8a6fa0b2-48e3-4c06-97c5-9ec3d6475a7c"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (62135-550-47)", "package_ndc": "62135-550-47", "marketing_start_date": "20230510"}], "brand_name": "Isoniazid", "product_id": "62135-550_44fdc5f6-d8fc-49a1-e063-6394a90ad33c", "dosage_form": "SOLUTION", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "62135-550", "generic_name": "Isoniazid", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isoniazid", "active_ingredients": [{"name": "ISONIAZID", "strength": "50 mg/5mL"}], "application_number": "ANDA081118", "marketing_category": "ANDA", "marketing_start_date": "19970721", "listing_expiration_date": "20261231"}