Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
ASCLEMED USA INC. DBA ENOVACHEM
Asclemed USA, Inc.
059888437
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
EPIPEN
Product Details
NDC Product Code
76420-584Application Number
NDA019430Marketing Category
NDA (C73594)Route of Administration
INTRAMUSCULAREffective Date
August 29, 2023SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
EpinephrineActive
Code: YKH834O4BHClass: ACTIBQuantity: 0.3 mg in 0.3 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT