SCOPOLAMINE patch, extended release

Scopolamine by

Drug Labeling and Warnings

Scopolamine by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SCOPOLAMINE 
scopolamine patch, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1787
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SCOPOLAMINE (UNII: DL48G20X8X) (SCOPOLAMINE - UNII:DL48G20X8X)	SCOPOLAMINE	1 mg  in 3 d

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1787-2	10 in 1 CARTON	09/05/2024
1		1 in 1 POUCH
1		3 d in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 70771-1787-7	24 in 1 CARTON	09/05/2024
2		1 in 1 POUCH
2		3 d in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 70771-1787-4	4 in 1 CARTON	09/05/2024
3	NDC: 70771-1787-1	1 in 1 POUCH
3		3 d in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA217893	09/05/2024

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		650461283	ANALYSIS(70771-1787) , MANUFACTURE(70771-1787)