"58602-816-67" National Drug Code (NDC)

Naproxen Sodium And Pseudoephedrine Hydrochloride Sinus And Cold 2 BLISTER PACK in 1 CARTON (58602-816-67) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
(Aurohealth LLC)

NDC Code58602-816-67
Package Description2 BLISTER PACK in 1 CARTON (58602-816-67) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product NDC58602-816
Product Type NameHUMAN OTC DRUG
Proprietary NameNaproxen Sodium And Pseudoephedrine Hydrochloride Sinus And Cold
Non-Proprietary NameNaproxen Sodium And Pseudoephedrine Hydrochloride
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20220601
Marketing Category NameANDA
Application NumberANDA211360
ManufacturerAurohealth LLC
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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