INSTANYL- fentanyl nasal spray spray

Instanyl by

Drug Labeling and Warnings

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

Drug Details [pdf]

Device Label

INGREDIENTS AND APPEARANCE

INSTANYL 
fentanyl nasal spray spray

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49396-0512
Route of Administration	NASAL	DEA Schedule	CII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FENTANYL CITRATE (UNII: MUN5LYG46H) (FENTANYL - UNII:UF599785JZ)	FENTANYL	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49396-0512-1	50 in 1 CARTON	06/29/2011
1		0.125 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		06/29/2011

Labeler - Renaissance Lakewood LLC (077744035)

Registrant - Renaissance Lakewood LLC (077744035)

Establishment
Name	Address	ID/FEI	Business Operations
Renaissance Lakewood LLC		077744035	manufacture(49396-0512) , analysis(49396-0512)