SPRAVATO- esketamine spray 
Renaissance Lakewood LLC

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Spravato (esketamine) EMA

Renaissance label

Shipper Label

SPRAVATO 
esketamine spray
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49396-0280
Route of AdministrationNASALDEA ScheduleCIII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESKETAMINE (UNII: 50LFG02TXD) (ESKETAMINE - UNII:50LFG02TXD) ESKETAMINE28 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49396-0280-22 in 1 CARTON12/18/2019
11 in 1 BLISTER PACK
11 in 1 VIAL; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:49396-0280-33 in 1 CARTON12/18/2019
21 in 1 BLISTER PACK
21 in 1 VIAL; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only12/18/2019
Labeler - Renaissance Lakewood LLC (077744035)
Registrant - Renaissance Lakewood LLC (077744035)
Establishment
NameAddressID/FEIBusiness Operations
Renaissance Lakewood LLC077744035manufacture(49396-0280) , analysis(49396-0280)

Revised: 12/2019
Document Id: 9a24d357-94da-4a64-e053-2995a90a09a2
Set id: 8281a6a3-b942-098e-e053-2a91aa0a874c
Version: 2
Effective Time: 20191220
 
Renaissance Lakewood LLC