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 10 mg/10 mL (1 mg/mL) Multiple Dose Vial, for intravenous, intramuscular, subcutaneous use Initial U.S. Approval: 1939
Approved
Approval ID
3fd8dd51-0aeb-43dd-9de0-c11b0330b15e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2023
Manufacturers
FDA
BPI Labs, LLC
DUNS: 078627620
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 Code54288-600
Application NumberNDA205029
Product Classification
M
Marketing Category
C73594
G
Generic Name
EPINEPHRINE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Quantity: 7.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 0.5 1 in 1 mL
Code: 4VON5FNS3C
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CHLOROBUTANOLInactive
Quantity: 5 mg in 1 mL
Code: HM4YQM8WRC
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EPINEPHRINEActive
Quantity: 1 mg in 1 mL
Code: YKH834O4BH
Classification: ACTIB