EpiPen
EpiPen (epinephrine) Auto-Injector 0.3 mgEpiPen = one dose of 0.30 mg epinephrine (USP, 1:1000, 0.3 mL)EpiPen JR(epinephrine) Auto-Injector 0.15 mgEpiPen Jr = one dose of 0.15 mg epinephrine (USP, 1:2000, 0.3 mL)
Approved
Approval ID
e47dc072-9cab-468e-851c-08c01652f447
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 14, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-4819
Application NumberNDA019430
Product Classification
M
Marketing Category
C73594
G
Generic Name
epinephrine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMay 14, 2012
FDA Product Classification
INGREDIENTS (6)
EPINEPHRINEActive
Quantity: 0.15 mg in 0.3 mL
Code: YKH834O4BH
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
epinephrine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2804
Application NumberNDA019430
Product Classification
M
Marketing Category
C73594
G
Generic Name
epinephrine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMay 14, 2012
FDA Product Classification
INGREDIENTS (6)
EPINEPHRINEActive
Quantity: 0.3 mg in 0.3 mL
Code: YKH834O4BH
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT