"0378-4124-01" National Drug Code (NDC)

Albuterol Sulfate 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4124-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-4124-01
Package Description100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4124-01)
Product NDC0378-4124
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAlbuterol Sulfate
Non-Proprietary NameAlbuterol Sulfate
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20070130
Marketing Category NameANDA
Application NumberANDA078092
ManufacturerMylan Pharmaceuticals Inc.
Substance NameALBUTEROL SULFATE
Strength8
Strength Unitmg/1
Pharmacy ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

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