NDC 45802-580

Scopolamine Trandermal System

Scolopamine Transdermal System

Scopolamine Trandermal System is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is Scopolamine.

Product ID45802-580_0eb1990f-9647-4494-b1c8-522dfc102804
NDC45802-580
Product TypeHuman Prescription Drug
Proprietary NameScopolamine Trandermal System
Generic NameScolopamine Transdermal System
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2017-06-13
Marketing CategoryANDA / ANDA
Application NumberANDA078830
Labeler NamePadagis Israel Pharmaceuticals Ltd
Substance NameSCOPOLAMINE
Active Ingredient Strength1 mg/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 45802-580-01

1 PATCH, EXTENDED RELEASE in 1 POUCH (45802-580-01)
Marketing Start Date2017-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45802-580-84 [45802058084]

Scopolamine Trandermal System PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078830
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-13

NDC 45802-580-62 [45802058062]

Scopolamine Trandermal System PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078830
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-13

NDC 45802-580-01 [45802058001]

Scopolamine Trandermal System PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078830
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-13

NDC 45802-580-46 [45802058046]

Scopolamine Trandermal System PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078830
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-13

Drug Details

Active Ingredients

IngredientStrength
SCOPOLAMINE1 mg/1

OpenFDA Data

SPL SET ID:cb93bfad-3e37-4a27-92f6-f21703ae7bdf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 226552

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    Medicade Reported Pricing

    45802058084 SCOPOLAMINE 1 MG/3 DAY PATCH

    Pricing Unit: EA | Drug Type:

    45802058062 SCOPOLAMINE 1 MG/3 DAY PATCH

    Pricing Unit: EA | Drug Type:

    45802058046 SCOPOLAMINE 1 MG/3 DAY PATCH

    Pricing Unit: EA | Drug Type:

    45802058001 SCOPOLAMINE 1 MG/3 DAY PATCH

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Scopolamine Trandermal System" or generic name "Scolopamine Transdermal System"

    NDCBrand NameGeneric Name
    45802-580Scopolamine Trandermal Systemscolopamine transdermal system
    63629-8450Scopolamine Trandermal Systemscolopamine transdermal system
    63629-8451Scopolamine Trandermal Systemscolopamine transdermal system
    63629-8452Scopolamine Trandermal Systemscolopamine transdermal system
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