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.
6% HETASTARCH IN 0.9% SODIUM CHLORIDE
Product Details
NDC Product Code
51662-1317Application Number
BA740193Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
January 29, 2024WATERInactive
Code: 059QF0KO0RClass: IACT
Hydroxyethyl StarchActive
Code: 875Y4127EAClass: ACTIBQuantity: 6 g in 100 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.9 g in 100 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT