"0378-9671-58" National Drug Code (NDC)

Ipratropium Bromide And Albuterol Sulfate 6 POUCH in 1 CARTON (0378-9671-58) > 5 AMPULE in 1 POUCH (0378-9671-98) > 3 mL in 1 AMPULE
(Mylan Pharmaceuticals, Inc.)

NDC Code0378-9671-58
Package Description6 POUCH in 1 CARTON (0378-9671-58) > 5 AMPULE in 1 POUCH (0378-9671-98) > 3 mL in 1 AMPULE
Product NDC0378-9671
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIpratropium Bromide And Albuterol Sulfate
Non-Proprietary NameIpratropium Bromide And Albuterol Sulfate
Dosage FormSOLUTION
UsageRESPIRATORY (INHALATION)
Start Marketing Date20130301
Marketing Category NameANDA
Application NumberANDA202496
ManufacturerMylan Pharmaceuticals, Inc.
Substance NameIPRATROPIUM BROMIDE; ALBUTEROL SULFATE
Strength.5; 2.5
Strength Unitmg/3mL; mg/3mL
Pharmacy ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

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