MedPath
FDA Approval

Instanyl

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
March 3, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fentanyl(2 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Instanyl

Product Details

NDC Product Code
49396-0512
Route of Administration
NASAL
Effective Date
March 3, 2023
WATERInactive
Code: 059QF0KO0RClass: IACT
FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 2 mg in 1 mL
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74Class: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SWClass: IACT
© Copyright 2025. All Rights Reserved by MedPath