NDC Code(s) : 72162-1419-2
Packager : Bryant Ranch Prepack

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:72162-1419(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 (120 .MU.M)(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:72162-1419-224 in 1 CARTON 30/08/2023
11 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078830 06/13/2017

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(72162-1419), RELABEL(72162-1419)

PRINCIPAL DISPLAY PANEL

Scopolamine 1 mg Transdermal System, #24

Label