clemastine fumarate

Generic: clemastine fumarate

Labeler: genus lifesciences
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clemastine fumarate
Generic Name clemastine fumarate
Labeler genus lifesciences
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clemastine fumarate 2.68 mg/1

Manufacturer
Genus Lifesciences

Identifiers & Regulatory

Product NDC 64950-268
Product ID 64950-268_813d92a9-7e67-455e-9158-6aa5af5b27a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073283
Listing Expiration 2026-12-31
Marketing Start 2024-11-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64950268
Hyphenated Format 64950-268

Supplemental Identifiers

RxCUI
857461
UNII
19259EGQ3D

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 clemastine fumarate (source: ndc)
Generic Name clemastine fumarate (source: ndc)
Application Number ANDA073283 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.68 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (64950-268-03)
  • 100 TABLET in 1 BOTTLE (64950-268-10)
source: ndc

Packages (2)

64950-268-03 30 TABLET in 1 BOTTLE (64950-268-03) 64950-268-10 100 TABLET in 1 BOTTLE (64950-268-10)

Ingredients (1)

clemastine fumarate (2.68 mg/1)

Linked Drug Pages (1)

Clemastine Fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "813d92a9-7e67-455e-9158-6aa5af5b27a7", "openfda": {"unii": ["19259EGQ3D"], "rxcui": ["857461"], "spl_set_id": ["cf8a3449-8bb3-4d5c-8d0d-557590e49ee5"], "manufacturer_name": ["Genus Lifesciences"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (64950-268-03)", "package_ndc": "64950-268-03", "marketing_start_date": "20241120"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (64950-268-10)", "package_ndc": "64950-268-10", "marketing_start_date": "20241120"}], "brand_name": "Clemastine Fumarate", "product_id": "64950-268_813d92a9-7e67-455e-9158-6aa5af5b27a7", "dosage_form": "TABLET", "product_ndc": "64950-268", "generic_name": "Clemastine Fumarate", "labeler_name": "Genus Lifesciences", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clemastine Fumarate", "active_ingredients": [{"name": "CLEMASTINE FUMARATE", "strength": "2.68 mg/1"}], "application_number": "ANDA073283", "marketing_category": "ANDA", "marketing_start_date": "20241120", "listing_expiration_date": "20261231"}