clemsza

Generic: clemastine fumarate

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

Drug Facts

Product Profile

Brand Name clemsza
Generic Name clemastine fumarate
Labeler ipg pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clemastine fumarate 2.68 mg/1

Manufacturer
IPG Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 71085-081
Product ID 71085-081_3b2a232e-e840-b8e1-e063-6394a90ae51d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073283
Listing Expiration 2026-12-31
Marketing Start 2025-08-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71085081
Hyphenated Format 71085-081

Supplemental Identifiers

RxCUI
857461 2720338
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 clemsza (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 (71085-081-30)
source: ndc

Packages (1)

71085-081-30 30 TABLET in 1 BOTTLE (71085-081-30)

Ingredients (1)

clemastine fumarate (2.68 mg/1)

Linked Drug Pages (1)

CLEMSZA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b2a232e-e840-b8e1-e063-6394a90ae51d", "openfda": {"unii": ["19259EGQ3D"], "rxcui": ["857461", "2720338"], "spl_set_id": ["9a35ed77-e35c-4c54-ad7f-1b92e450fa20"], "manufacturer_name": ["IPG Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71085-081-30)", "package_ndc": "71085-081-30", "marketing_start_date": "20250801"}], "brand_name": "CLEMSZA", "product_id": "71085-081_3b2a232e-e840-b8e1-e063-6394a90ae51d", "dosage_form": "TABLET", "product_ndc": "71085-081", "generic_name": "Clemastine Fumarate", "labeler_name": "IPG Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLEMSZA", "active_ingredients": [{"name": "CLEMASTINE FUMARATE", "strength": "2.68 mg/1"}], "application_number": "ANDA073283", "marketing_category": "ANDA", "marketing_start_date": "20250801", "listing_expiration_date": "20261231"}