Label: SCOPOLAMINE patch, extended release
- NDC Code(s): 70771-1787-1, 70771-1787-2, 70771-1787-4, 70771-1787-7
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 12, 2024
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INGREDIENTS AND APPEARANCE
SCOPOLAMINE
scopolamine patch, extended releaseProduct 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 863362789 ANALYSIS(70771-1787) , MANUFACTURE(70771-1787)
