SPRAVATO- esketamine spray

Spravato by

Drug Labeling and Warnings

Spravato by is a Prescription medication manufactured, distributed, or labeled by Renaissance Lakewood LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Renaissance label

INGREDIENTS AND APPEARANCE

SPRAVATO 
esketamine spray

Product 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)