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
Products1
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
51662-1629Application Number
NDA211363Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
January 22, 2024SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 1.5 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8.2 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
NITROGENInactive
Code: N762921K75Class: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 3.3 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.004 mg in 1 mL
EpinephrineActive
Code: YKH834O4BHClass: ACTIBQuantity: 0.1 mg in 1 mL