epinephrine
epinephrine injection, USP auto-injector
Approved
Approval ID
ad07e9bf-cc81-4736-86c7-2b2de9386eb2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 22, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-947
Application NumberNDA020800
Product Classification
M
Marketing Category
C73605
G
Generic Name
epinephrine
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 17, 2011
FDA Product Classification
INGREDIENTS (4)
EPINEPHRINEActive
Quantity: 0.3 mg in 1 1
Code: YKH834O4BH
Classification: ACTIB
CHLOROBUTANOLInactive
Code: HM4YQM8WRC
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BISULFITEInactive
Code: TZX5469Z6I
Classification: IACT