Benztropine Mesylate
BENZTROPINE MESYLATE TABLETS USP
Approved
Approval ID
c3b5953d-75f1-4a2a-af52-618915344b58
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 7, 2021
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 3
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 Code0603-2439
Application NumberANDA204713
Product Classification
M
Marketing Category
C73584
G
Generic Name
benztropine mesylate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2023
FDA Product Classification
INGREDIENTS (5)
BENZTROPINE MESYLATEActive
Quantity: 2 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
benztropine mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0603-2438
Application NumberANDA204713
Product Classification
M
Marketing Category
C73584
G
Generic Name
benztropine mesylate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2023
FDA Product Classification
INGREDIENTS (5)
BENZTROPINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
benztropine mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0603-2437
Application NumberANDA204713
Product Classification
M
Marketing Category
C73584
G
Generic Name
benztropine mesylate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2023
FDA Product Classification
INGREDIENTS (5)
BENZTROPINE MESYLATEActive
Quantity: 0.5 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT