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CLEMASTINE FUMARATE

Clemastine Fumarate Syrup

Approved
Approval ID

6663f1b0-5353-401f-b9d3-d9f69ad08fbf

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 7, 2023

Manufacturers
FDA

Chartwell RX, LLC

DUNS: 079394054

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 Code62135-713
Application NumberANDA074884
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLEMASTINE FUMARATE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2023
FDA Product Classification

INGREDIENTS (10)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CLEMASTINE FUMARATEActive
Quantity: 0.67 mg in 5 mL
Code: 19259EGQ3D
Classification: ACTIB

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CLEMASTINE FUMARATE - FDA Drug Approval Details