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Benztropine Mesylate

BENZTROPINE MESYLATE TABLETS, USP

Approved
Approval ID

0c4af880-ec99-4bbe-a250-903770dcd461

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 12, 2010

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

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

NDC Product Code53808-0211
Application NumberANDA089059
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 12, 2010
Generic NameBenztropine Mesylate

INGREDIENTS (6)

BENZTROPINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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Benztropine Mesylate - FDA Drug Approval Details