"65162-438-10" National Drug Code (NDC)

Diclofenac Sodium And Misoprostol 100 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-10)
(Amneal Pharmaceuticals LLC)

NDC Code65162-438-10
Package Description100 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-10)
Product NDC65162-438
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDiclofenac Sodium And Misoprostol
Non-Proprietary NameDiclofenac Sodium And Misoprostol
Dosage FormTABLET, DELAYED RELEASE
UsageORAL
Start Marketing Date20161201
Marketing Category NameANDA
Application NumberANDA203995
ManufacturerAmneal Pharmaceuticals LLC
Substance NameDICLOFENAC SODIUM; MISOPROSTOL
Strength75; 200
Strength Unitmg/1; ug/1
Pharmacy ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]

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