Scopolamine
These highlights do not include all the information needed to use SCOPOLAMINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for SCOPOLAMINE TRANSDERMAL SYSTEM. SCOPOLAMINE transdermal systemInitial U.S. Approval: 1979
Approved
Approval ID
2a6f9aaf-a70a-481f-a82b-1dcaaadc185b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 24, 2023
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Scopolamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-505
Application NumberANDA212342
Product Classification
M
Marketing Category
C73584
G
Generic Name
Scopolamine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateMarch 9, 2022
FDA Product Classification
INGREDIENTS (7)
SCOPOLAMINEActive
Quantity: 1.5 mg in 1 1
Code: DL48G20X8X
Classification: ACTIB
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
POLYTETRAFLUOROETHYLENEInactive
Code: E1NC1JVS3O
Classification: IACT
D&C BLACK NO. 2Inactive
Code: 4XYU5U00C4
Classification: IACT
CINQUASIA REDInactive
Code: 11P487375P
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT