Instanyl
Instanyl Fentanyl Nasal Spray
Approved
Approval ID
92c19d5a-0fe2-777d-e053-2995a90a4f3f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 3, 2023
Manufacturers
FDA
Renaissance Lakewood LLC
DUNS: 077744035
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fentanyl Nasal Spray
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49396-0512
Product Classification
G
Generic Name
Fentanyl Nasal Spray
Product Specifications
Route of AdministrationNASAL
Effective DateMarch 3, 2023
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FENTANYL CITRATEActive
Quantity: 2 mg in 1 mL
Code: MUN5LYG46H
Classification: ACTIM
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT