MedPath

CLEMASZ

CLEMASZ ™ (Clemastine Fumarate Tablets, USP) Rx only

Approved
Approval ID

861f5615-297e-44af-a7eb-1095dc29d0a0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 3, 2025

Manufacturers
FDA

New HeightsRx, LLC

DUNS: 119177168

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Clemastine Fumarate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84044-268
Application NumberANDA073283
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clemastine Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateMay 3, 2025
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CLEMASTINE FUMARATEActive
Quantity: 2.68 mg in 1 1
Code: 19259EGQ3D
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/3/2025

PRINCIPAL DISPLAY PANEL - 2.68 mg Tablet Bottle Label

NDC 84044-268-03

Clemastine
Fumarate
Tablets, USP

2.68 mg

Rx only
30 Tablets

New HeightsRx, LLC.

PRINCIPAL DISPLAY PANEL - 2.68 mg Tablet Bottle Label

DESCRIPTION SECTION

LOINC: 34089-3Updated: 4/3/2025

DESCRIPTION

Clemastine belongs to the benzhydryl ether group of antihistaminic compounds. The chemical name is (+)-(2 R)-2-[2-[[( R)- p-Chloro-α-methyl-α- phenylbenzyl]-oxy]ethyl]-1-methylpyrrolidine fumarate (1:1).

Chemical Structure

C 21H 26C1NO∙C 4H 4O 4

M.W. 459.97

Each tablet for oral administration contains 2.68 mg of clemastine fumarate, USP.

Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, povidone, pregelatinized starch and stearic acid.

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