"85043-316-70" National Drug Code (NDC)

Leuprolide Acetate For Injectable Suspension 1 SYRINGE in 1 CARTON (85043-316-70) / .5 mL in 1 SYRINGE
(URONOVA PHARMACEUTICALS, INC.)

NDC Code85043-316-70
Package Description1 SYRINGE in 1 CARTON (85043-316-70) / .5 mL in 1 SYRINGE
Product NDC85043-316
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameLeuprolide Acetate For Injectable Suspension
Non-Proprietary NameLeuprolide Acetate
Dosage FormINJECTION, SUSPENSION, EXTENDED RELEASE
UsageSUBCUTANEOUS
Start Marketing Date20250601
Marketing Category NameNDA AUTHORIZED GENERIC
Application NumberNDA021488
ManufacturerURONOVA PHARMACEUTICALS, INC.
Substance NameLEUPROLIDE ACETATE
Strength30
Strength Unitmg/.5mL
Pharmacy ClassesGonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]

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