BENZTROPINE MESYLATE
BENZTROPINE MESYLATE Tablets USP0.5 mg, 1 mg and 2 mgBayshore Pharmaceuticals LLC Rx only
Approved
Approval ID
298f140d-b4e4-4cc6-a304-b32eaba3f0b0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2021
Manufacturers
FDA
Bayshore Pharmaceuticals LLC (NJ)
DUNS: 968737416
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 Code76385-104
Application NumberANDA090168
Product Classification
M
Marketing Category
C73584
G
Generic Name
BENZTROPINE MESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 14, 2019
FDA Product Classification
INGREDIENTS (8)
BENZTROPINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
BENZTROPINE MESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76385-103
Application NumberANDA090168
Product Classification
M
Marketing Category
C73584
G
Generic Name
BENZTROPINE MESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 14, 2019
FDA Product Classification
INGREDIENTS (8)
BENZTROPINE MESYLATEActive
Quantity: 0.5 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BENZTROPINE MESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76385-105
Application NumberANDA090168
Product Classification
M
Marketing Category
C73584
G
Generic Name
BENZTROPINE MESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 14, 2019
FDA Product Classification
INGREDIENTS (8)
BENZTROPINE MESYLATEActive
Quantity: 2 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT