"50580-434-01" National Drug Code (NDC)

Sudafed Sinus 12 Hour Pressure Plus Pain 2 BLISTER PACK in 1 CARTON (50580-434-01) / 8 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
(Johnson & Johnson Consumer Inc.)

NDC Code50580-434-01
Package Description2 BLISTER PACK in 1 CARTON (50580-434-01) / 8 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
Product NDC50580-434
Product Type NameHUMAN OTC DRUG
Proprietary NameSudafed Sinus 12 Hour Pressure Plus Pain
Non-Proprietary NameNaproxen Sodium And Pseudoephedrine Hydrochloride
Dosage FormTABLET, MULTILAYER, EXTENDED RELEASE
UsageORAL
Start Marketing Date20190617
Marketing Category NameANDA
Application NumberANDA076518
ManufacturerJohnson & Johnson Consumer Inc.
Substance NameNAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength220; 120
Strength Unitmg/1; mg/1
Pharmacy ClassesAdrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC]

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