Clemastine Fumarate

Product NDC
64950-268
11-digit product format
649500268
Labeler code
64950
Product ID
64950-268_813d92a9-7e67-455e-9158-6aa5af5b27a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clemastine Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Genus Lifesciences
Application
ANDA073283
Marketing category
ANDA
Marketing start
2024-11-20
Substance
CLEMASTINE FUMARATE
Active strength
2.68 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clemastine Fumarate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLEMASTINE FUMARATE2.68 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19259EGQ3D
Rxcui857461

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f7e17947-a18d-ce47-e13b-48f8b11c0c6fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64950-268-03Clemastine Fumarate30 in 1 BOTTLETABLET302
64950-268-10Clemastine Fumarate100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64950-268-10EA - Each64950-268ffab3bdf-9456-4f8d-9233-e80f30a3d7e812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64950-268CLEMASTINE FUMARATE TABLET [GENUS LIFESCIENCES]2Current NDC, 2 package rows20250206_cf8a3449-8bb3-4d5c-8d0d-557590e49ee5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857461clemastine fumarate 2.68 MG Oral TabletPSNcf8a3449-8bb3-4d5c-8d0d-557590e49ee52
857461clemastine fumarate 2.68 MG Oral TabletSCDcf8a3449-8bb3-4d5c-8d0d-557590e49ee52
857461clemastine 2 MG Oral TabletSYcf8a3449-8bb3-4d5c-8d0d-557590e49ee52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64950-268-036495002680330 TABLET in 1 BOTTLE (64950-268-03) 30 tablet2024-11-20NoNoHistorical
64950-268-1064950026810100 TABLET in 1 BOTTLE (64950-268-10) 100 tablet2024-11-20NoNoHistorical