Benztropine Mesylate
Benztropine Mesylate Tablets, USP
Approved
Approval ID
3d2732f9-b8a9-4e83-91e7-da616ddcb786
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2020
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benztropine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-827
Application NumberANDA090294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benztropine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2018
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
BENZTROPINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Benztropine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-826
Application NumberANDA090294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benztropine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2018
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
BENZTROPINE MESYLATEActive
Quantity: 0.5 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Benztropine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-832
Application NumberANDA090294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benztropine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2018
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BENZTROPINE MESYLATEActive
Quantity: 2 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB