"45802-578-84" National Drug Code (NDC)

Naloxone Hydrochloride 2 VIAL, SINGLE-DOSE in 1 CARTON (45802-578-84) / .1 mL in 1 VIAL, SINGLE-DOSE (45802-578-00)
(Padagis Israel Pharmaceuticals Ltd)

NDC Code45802-578-84
Package Description2 VIAL, SINGLE-DOSE in 1 CARTON (45802-578-84) / .1 mL in 1 VIAL, SINGLE-DOSE (45802-578-00)
Product NDC45802-578
Product Type NameHUMAN OTC DRUG
Proprietary NameNaloxone Hydrochloride
Non-Proprietary NameNaloxone Hydrochloride
Dosage FormSPRAY
UsageNASAL
Start Marketing Date20230730
Marketing Category NameANDA
Application NumberANDA211951
ManufacturerPadagis Israel Pharmaceuticals Ltd
Substance NameNALOXONE HYDROCHLORIDE
Strength4
Strength Unitmg/.1mL
Pharmacy ClassesOpioid Antagonist [EPC], Opioid Antagonists [MoA]

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