isoniazid

Generic: isoniazid

Labeler: cmp pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isoniazid
Generic Name isoniazid
Labeler cmp pharma, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

isoniazid 50 mg/5mL

Manufacturer
CMP Pharma, Inc.

Identifiers & Regulatory

Product NDC 46287-009
Product ID 46287-009_b4455fa7-39e3-41a5-9a5b-5ff7c490de89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088235
Listing Expiration 2026-12-31
Marketing Start 1983-11-11

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46287009
Hyphenated Format 46287-009

Supplemental Identifiers

RxCUI
105292
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 ANDA088235 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (46287-009-01)
source: ndc

Packages (1)

46287-009-01 473 mL in 1 BOTTLE (46287-009-01)

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": "b4455fa7-39e3-41a5-9a5b-5ff7c490de89", "openfda": {"nui": ["N0000175483"], "unii": ["V83O1VOZ8L"], "rxcui": ["105292"], "spl_set_id": ["db8a3ae7-fb5b-47a9-a9f7-f57cd90501c2"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "manufacturer_name": ["CMP Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (46287-009-01)", "package_ndc": "46287-009-01", "marketing_start_date": "19831111"}], "brand_name": "Isoniazid", "product_id": "46287-009_b4455fa7-39e3-41a5-9a5b-5ff7c490de89", "dosage_form": "SOLUTION", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "46287-009", "generic_name": "isoniazid", "labeler_name": "CMP Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isoniazid", "active_ingredients": [{"name": "ISONIAZID", "strength": "50 mg/5mL"}], "application_number": "ANDA088235", "marketing_category": "ANDA", "marketing_start_date": "19831111", "listing_expiration_date": "20261231"}