NDC Code(s) : 45802-580-84, 45802-580-46, 45802-580-62, 45802-580-01
Packager : Padagis Israel Pharmaceuticals Ltd

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Scopolamine Trandermal Systemscolopamine transdermal system PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-580
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SCOPOLAMINE(UNII: DL48G20X8X)
(SCOPOLAMINE - UNII:DL48G20X8X) 		SCOPOLAMINE1 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
LIGHT MINERAL OIL(UNII: N6K5787QVP)
POLYISOBUTYLENE (55000 MW)(UNII: TQ77WR8A02)
POLYISOBUTYLENE (1100000 MW)(UNII: FLT10CH37X)
Product Characteristics
Color white (TO ALMOST WHITE) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45802-580-844 in 1 CARTON 13/06/2017
11 in 1 POUCH Type 0: Not a Combination Product
2NDC:45802-580-4610 in 1 CARTON 13/06/2017
21 in 1 POUCH Type 0: Not a Combination Product
3NDC:45802-580-6224 in 1 CARTON 13/06/2017
31 in 1 POUCH Type 0: Not a Combination Product
4NDC:45802-580-011 in 1 POUCH Type 0: Not a Combination Product13/06/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078830 06/13/2017

LABELER - Padagis Israel Pharmaceuticals Ltd(600093611)

Establishment
Name Address ID/FEI Business Operations
Aveva Drug Delivery Systems Inc. 783982093 analysis(45802-580), manufacture(45802-580)

PRINCIPAL DISPLAY PANEL

Rx Only

Scopolamine Transdermal System

1 mg/3 days

Formulated delivery of approximately 1 mg over three days

Motion Sickness and Post-operative Nausea & Vomiting Prevention Transdermal Systems

24 Transdermal Systems

carton-rev05-19

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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