Label: SPRAVATO- esketamine spray
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- NDC Code(s): 49396-0280-2, 49396-0280-3
- Packager: Renaissance Lakewood LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: CIII
- Marketing Status: Export only
Drug Label Information
Updated December 20, 2019
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INGREDIENTS AND APPEARANCE
SPRAVATO
esketamine sprayProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49396-0280 Route of Administration NASAL DEA Schedule CIII Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESKETAMINE (UNII: 50LFG02TXD) (ESKETAMINE - UNII:50LFG02TXD) ESKETAMINE 28 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49396-0280-2 2 in 1 CARTON 12/18/2019 1 1 in 1 BLISTER PACK 1 1 in 1 VIAL; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:49396-0280-3 3 in 1 CARTON 12/18/2019 2 1 in 1 BLISTER PACK 2 1 in 1 VIAL; 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 Export only 12/18/2019 Labeler - Renaissance Lakewood LLC (077744035) Registrant - Renaissance Lakewood LLC (077744035) Establishment Name Address ID/FEI Business Operations Renaissance Lakewood LLC 077744035 manufacture(49396-0280) , analysis(49396-0280)
