Clemastine Fumarate
Clemastine Fumarate Syrup
Approved
Approval ID
63a3789a-8fe9-4149-8b7d-d7e6d32aadc5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 3, 2023
Manufacturers
FDA
Ayurax, LLC
DUNS: 117147643
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 Code73308-358
Application NumberANDA073399
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clemastine Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 4, 2021
FDA Product Classification
INGREDIENTS (10)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CLEMASTINE FUMARATEActive
Quantity: 0.67 mg in 5 mL
Code: 19259EGQ3D
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
MALEIC ACIDInactive
Code: 91XW058U2C
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT