EPIPEN
These highlights do not include all the information needed to use EPIPEN safely and effectively. See full prescribing information for EPIPEN. EPIPEN (epinephrine injection), for intramuscular or subcutaneous use Initial U.S. Approval: 1939
Approved
Approval ID
311af6d9-20c0-4b87-b236-4185bfa49988
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 29, 2023
Manufacturers
FDA
Asclemed USA, Inc.
DUNS: 059888437
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
epinephrine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76420-584
Application NumberNDA019430
Product Classification
M
Marketing Category
C73594
G
Generic Name
epinephrine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateAugust 29, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EPINEPHRINEActive
Quantity: 0.3 mg in 0.3 mL
Code: YKH834O4BH
Classification: ACTIB
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT