Scopolamine Trandermal System
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . SCOPOLAMINE transdermal system 1 mg/3 days Initial U.S. Approval: 1979
Approved
Approval ID
69401d6f-3d18-48b0-b28c-a578c9834f32
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
scolopamine transdermal system
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72162-1419
Application NumberANDA078830
Product Classification
M
Marketing Category
C73584
G
Generic Name
scolopamine transdermal system
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (6)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
POLYISOBUTYLENE (55000 MW)Inactive
Code: TQ77WR8A02
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
POLYISOBUTYLENE (1100000 MW)Inactive
Code: FLT10CH37X
Classification: IACT
SCOPOLAMINEActive
Quantity: 1 mg in 1 1
Code: DL48G20X8X
Classification: ACTIB