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Benztropine Mesylate

BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg

Approved
Approval ID

4f03e640-f945-4bbe-8a66-b13b3996ed57

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 30, 2011

Manufacturers
FDA

Dispensing Solutions, Inc.

DUNS: 066070785

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 Code66336-776
Application NumberANDA040742
Product Classification
M
Marketing Category
C73584
G
Generic Name
benztropine mesylate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2011
FDA Product Classification

INGREDIENTS (6)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
BENZTROPINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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Benztropine Mesylate - FDA Drug Approval Details