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