Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
EpiPen Jr
Product Details
NDC Product Code
54868-4819Application Number
NDA019430Marketing Category
NDA (C73594)Route of Administration
INTRAMUSCULAREffective Date
May 14, 2012EpinephrineActive
Code: YKH834O4BHClass: ACTIBQuantity: 0.15 mg in 0.3 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
NITROGENInactive
Code: N762921K75Class: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
EpiPen
Product Details
NDC Product Code
54868-2804Application Number
NDA019430Marketing Category
NDA (C73594)Route of Administration
INTRAMUSCULAREffective Date
May 14, 2012EpinephrineActive
Code: YKH834O4BHClass: ACTIBQuantity: 0.3 mg in 0.3 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
NITROGENInactive
Code: N762921K75Class: IACT