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"0378-9691-52" National Drug Code (NDC)

Levalbuterol 1 POUCH in 1 CARTON (0378-9691-52) > 25 AMPULE in 1 POUCH (0378-9691-62) > 3 mL in 1 AMPULE
(Mylan Pharmaceuticals Inc.)

NDC Code0378-9691-52
Package Description1 POUCH in 1 CARTON (0378-9691-52) > 25 AMPULE in 1 POUCH (0378-9691-62) > 3 mL in 1 AMPULE
Product NDC0378-9691
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameLevalbuterol
Non-Proprietary NameLevalbuterol
Dosage FormSOLUTION
UsageRESPIRATORY (INHALATION)
Start Marketing Date20180723
Marketing Category NameANDA
Application NumberANDA203653
ManufacturerMylan Pharmaceuticals Inc.
Substance NameLEVALBUTEROL HYDROCHLORIDE
Strength.63
Strength Unitmg/3mL
Pharmacy ClassesAdrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]

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