Spravato

Manufacturer: Renaissance Lakewood LLC
Effective date: 2019-12-20
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 23:49:39

Label at a glance#

ProductSpravato

Active ingredientESKETAMINE

Label structure1 sections

Label contents#

Full prescribing information#

Renaissance label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Shipper Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Spravato
Esketamine
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM ANHYDROUS
SODIUM HYDROXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49396-0280	49396-0280-2, 49396-0280-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
ESKETAMINE	50LFG02TXD	ACTIB
EDETATE DISODIUM ANHYDROUS	8NLQ36F6MM	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9a24d357-94da-4a64-e053-2995a90a09a2			8281a6a3-b942-098e-e053-2a91aa0a874c	2019-12-20		Exact identifier spl id: 9a24d357-94da-4a64-e053-2995a90a09a2 spl set id: 8281a6a3-b942-098e-e053-2a91aa0a874c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.