Transderm Scop
Transderm Scōp
Approved
Approval ID
f6fdc88b-ea00-4694-8f21-b8d15dbb339e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 26, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-2803
Application NumberNDA017874
Product Classification
M
Marketing Category
C73594
G
Generic Name
scopolamine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateMarch 26, 2013
FDA Product Classification
INGREDIENTS (5)
SCOPOLAMINEActive
Quantity: 1 mg in 3 d
Code: DL48G20X8X
Classification: ACTIB
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
POLYISOBUTYLENE (35000 MW)Inactive
Code: 98553S1MHQ
Classification: IACT
POLYISOBUTYLENE (1100000 MW)Inactive
Code: FLT10CH37X
Classification: IACT
CHLOROFORMInactive
Code: 7V31YC746X
Classification: IACT