clemastine fumarate

Generic: clemastine fumarate

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

Drug Facts

Product Profile

Brand Name clemastine fumarate
Generic Name clemastine fumarate
Labeler chartwell rx, llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

clemastine fumarate .67 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-713
Product ID 62135-713_ffe63870-181f-e007-e053-6294a90a074e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074884
Listing Expiration 2026-12-31
Marketing Start 1997-12-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135713
Hyphenated Format 62135-713

Supplemental Identifiers

RxCUI
857430
UPC
0362135713416
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 ANDA074884 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .67 mg/5mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (62135-713-41)
source: ndc

Packages (1)

62135-713-41 120 mL in 1 BOTTLE (62135-713-41)

Ingredients (1)

clemastine fumarate (.67 mg/5mL)

Linked Drug Pages (1)

CLEMASTINE FUMARATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ffe63870-181f-e007-e053-6294a90a074e", "openfda": {"upc": ["0362135713416"], "unii": ["19259EGQ3D"], "rxcui": ["857430"], "spl_set_id": ["6663f1b0-5353-401f-b9d3-d9f69ad08fbf"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (62135-713-41)", "package_ndc": "62135-713-41", "marketing_start_date": "20230707"}], "brand_name": "CLEMASTINE FUMARATE", "product_id": "62135-713_ffe63870-181f-e007-e053-6294a90a074e", "dosage_form": "SYRUP", "product_ndc": "62135-713", "generic_name": "CLEMASTINE FUMARATE", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLEMASTINE FUMARATE", "active_ingredients": [{"name": "CLEMASTINE FUMARATE", "strength": ".67 mg/5mL"}], "application_number": "ANDA074884", "marketing_category": "ANDA", "marketing_start_date": "19971217", "listing_expiration_date": "20261231"}