NDC Code(s) : 63629-8452-2, 63629-8452-1
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:63629-8452(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:63629-8452-14 in 1 CARTON 29/04/2021
1NDC:63629-8452-21 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(63629-8452), RELABEL(63629-8452)

PRINCIPAL DISPLAY PANEL

Scopolamine 1 mg Transdermal System, #4

Label