EPINEPHRINE
epinephrine injection, USP auto-injector
Approved
Approval ID
fee44162-aaf2-4e89-9f83-2d3a8ff76760
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6239
Application NumberNDA020800
Product Classification
M
Marketing Category
C73594
G
Generic Name
epinephrine
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 20, 2011
FDA Product Classification
INGREDIENTS (4)
CHLOROBUTANOLInactive
Code: HM4YQM8WRC
Classification: IACT
SODIUM BISULFITEInactive
Code: TZX5469Z6I
Classification: IACT
EPINEPHRINEActive
Quantity: 0.3 mg in 1 1
Code: YKH834O4BH
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT