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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

NDC Product Code72162-1419
Application NumberANDA078830
Marketing CategoryC73584
Route of AdministrationTRANSDERMAL
Effective DateDecember 5, 2023
Generic Namescolopamine transdermal system

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

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Scopolamine Trandermal System - FDA Drug Approval Details