SCOPOLAMINE- scopolamine patch, extended release 
Zydus Lifesciences Limited

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SCOPOLAMINE transdermal system

SPL UNCLASSIFIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Scopolamine transdermal system, 1 mg/3 days

Carton of 4 transdermal systems

NDC 70771-1787-4

Rx only

4's carton
SCOPOLAMINE 
scopolamine patch, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1787
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SCOPOLAMINE (UNII: DL48G20X8X) (SCOPOLAMINE - UNII:DL48G20X8X) SCOPOLAMINE1 mg  in 3 d
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1787-210 in 1 CARTON09/05/2024
11 in 1 POUCH
13 d in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:70771-1787-724 in 1 CARTON09/05/2024
21 in 1 POUCH
23 d in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:70771-1787-44 in 1 CARTON09/05/2024
3NDC:70771-1787-11 in 1 POUCH
33 d in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21789309/05/2024
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650461283ANALYSIS(70771-1787) , MANUFACTURE(70771-1787)

Revised: 8/2025
Document Id: 2bd0ca3f-183d-4af2-8c0e-962115d97fed
Set id: 016df9f3-61d5-45e9-b1d6-791a5d2f26d5
Version: 3
Effective Time: 20250823
 
Zydus Lifesciences Limited