Benztropine Mesylate
Benztropine Mesylate
Approved
Approval ID
e653f9bc-40db-4048-bcf2-6fa46db85895
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 22, 2019
Manufacturers
FDA
Marlex Pharmaceuticals Inc
DUNS: 782540215
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 Code10135-606
Application NumberANDA090168
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benztropine Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateMay 17, 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
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
Benztropine Mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-608
Application NumberANDA090168
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benztropine Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateMay 17, 2019
FDA Product Classification
INGREDIENTS (8)
BENZTROPINE MESYLATEActive
Quantity: 2 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
Benztropine Mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-607
Application NumberANDA090168
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benztropine Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateMay 17, 2019
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BENZTROPINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT