epinephrine
These highlights do not include all the information needed to use EPINEPHRINE INJECTION, USP AUTO-INJECTOR safely and effectively. See full prescribing information for EPINEPHRINE INJECTION, USP AUTO-INJECTOR. Epinephrine injection, USP auto-injector 0.3 mg, 0.15 mg, for intramuscular or subcutaneous use Initial U.S. Approval: 1939
Approved
Approval ID
4cc59056-a5ae-696d-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2019
Manufacturers
FDA
Sina Health Inc
DUNS: 047161553
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 Code70385-2017
Application NumberNDA020800
Product Classification
M
Marketing Category
C73605
G
Generic Name
epinephrine
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 4, 2019
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CHLOROBUTANOLInactive
Code: HM4YQM8WRC
Classification: IACT
SODIUM BISULFITEInactive
Code: TZX5469Z6I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EPINEPHRINEActive
Quantity: 0.15 mg in 0.15 mL
Code: YKH834O4BH
Classification: ACTIB