Epinephrine
These highlights do not include all the information needed to use EPINEPHRINE INJECTION safely and effectively. See full prescribing information for EPINEPHRINE INJECTION. EPINEPHRINE injection, for intramuscular or subcutaneous useInitial U.S. Approval: 1939
Approved
Approval ID
778ac6ae-6bcb-47a4-bcb3-8dd0da9f8836
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2023
Manufacturers
FDA
Mylan Specialty L.P.
DUNS: 194775557
Products 2
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 Code49502-101
Application NumberNDA019430
Product Classification
M
Marketing Category
C73605
G
Generic Name
Epinephrine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateAugust 31, 2018
FDA Product Classification
INGREDIENTS (5)
EPINEPHRINEActive
Quantity: 0.15 mg in 0.3 mL
Code: YKH834O4BH
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Epinephrine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49502-102
Application NumberNDA019430
Product Classification
M
Marketing Category
C73605
G
Generic Name
Epinephrine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateAugust 31, 2018
FDA Product Classification
INGREDIENTS (5)
EPINEPHRINEActive
Quantity: 0.3 mg in 0.3 mL
Code: YKH834O4BH
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT