Benztropine Mesylate
BENZTROPINE MESYLATE TABLETS USP
Approved
Approval ID
220f8561-bb1e-4646-9ba5-36934a7e40ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 8, 2022
Manufacturers
FDA
Cardinal Health 107, LLC
DUNS: 118546603
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
benztropine mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55154-8095
Application NumberANDA204713
Product Classification
M
Marketing Category
C73584
G
Generic Name
benztropine mesylate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2020
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BENZTROPINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT