Epinephrine
These highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION USP, for intravenous useInitial U.S. Approval: 1939
Approved
Approval ID
f2b5f15b-8541-466a-a27a-ee57bc4aac67
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2023
Manufacturers
FDA
International Medication Systems, Limited
DUNS: 055750020
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 Code76329-3318
Application NumberNDA211363
Product Classification
M
Marketing Category
C73594
G
Generic Name
Epinephrine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (9)
EPINEPHRINEActive
Quantity: 0.1 mg in 1 mL
Code: YKH834O4BH
Classification: ACTIB
SODIUM CITRATEInactive
Quantity: 1.5 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 3.3 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.004 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.2 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT