Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
HF Acquisition Co LLC, DBA HealthFirst
045657305
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
HF Acquisition Co LLC, DBA HealthFirst
HF Acquisition Co LLC, DBA HealthFirst
HF Acquisition Co LLC, DBA HealthFirst
045657305
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
EPINEPHRINE
Product Details
NDC Product Code
51662-1224Application Number
NDA019430Marketing Category
NDA (C73594)Route of Administration
INTRAMUSCULAREffective Date
December 9, 2022HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
EpinephrineActive
Code: YKH834O4BHClass: ACTIBQuantity: 0.3 mg in 0.3 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
EPINEPHRINE
Product Details
NDC Product Code
51662-1225Application Number
NDA019430Marketing Category
NDA (C73594)Route of Administration
INTRAMUSCULAREffective Date
December 9, 2022HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
EpinephrineActive
Code: YKH834O4BHClass: ACTIBQuantity: 0.15 mg in 0.3 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT