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"0480-3478-68" National Drug Code (NDC)

Naloxone Hydrochloride 2 BLISTER PACK in 1 CARTON (0480-3478-68) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0480-3478-19) / .1 mL in 1 VIAL, SINGLE-DOSE
(Teva Pharmaceuticals, Inc.)

NDC Code0480-3478-68
Package Description2 BLISTER PACK in 1 CARTON (0480-3478-68) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0480-3478-19) / .1 mL in 1 VIAL, SINGLE-DOSE
Product NDC0480-3478
Product Type NameHUMAN OTC DRUG
Proprietary NameNaloxone Hydrochloride
Non-Proprietary NameNaloxone Hydrochloride
Dosage FormSPRAY, METERED
UsageNASAL
Start Marketing Date20240923
Marketing Category NameANDA
Application NumberANDA209522
ManufacturerTeva Pharmaceuticals, Inc.
Substance NameNALOXONE HYDROCHLORIDE
Strength4
Strength Unitmg/.1mL
Pharmacy ClassesOpioid Antagonist [EPC], Opioid Antagonists [MoA]

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