"80425-0409-1" National Drug Code (NDC)

Naloxone Hydrochloride 2 VIAL, SINGLE-DOSE in 1 CARTON (80425-0409-1) / .1 mL in 1 VIAL, SINGLE-DOSE
(Advanced Rx of Tennessee, LLC)

NDC Code80425-0409-1
Package Description2 VIAL, SINGLE-DOSE in 1 CARTON (80425-0409-1) / .1 mL in 1 VIAL, SINGLE-DOSE
Product NDC80425-0409
Product Type NameHUMAN OTC DRUG
Proprietary NameNaloxone Hydrochloride
Non-Proprietary NameNaloxone Hydrochloride
Dosage FormSPRAY
UsageNASAL
Start Marketing Date20240627
Marketing Category NameANDA
Application NumberANDA211951
ManufacturerAdvanced Rx of Tennessee, LLC
Substance NameNALOXONE HYDROCHLORIDE
Strength4
Strength Unitmg/.1mL
Pharmacy ClassesOpioid Antagonist [EPC], Opioid Antagonists [MoA]

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