"0591-0398-19" National Drug Code (NDC)

Diclofenac Sodium And Misoprostol 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0398-19)
(Actavis Pharma, Inc.)

NDC Code0591-0398-19
Package Description90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0398-19)
Product NDC0591-0398
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDiclofenac Sodium And Misoprostol
Non-Proprietary NameDiclofenac Sodium And Misoprostol
Dosage FormTABLET, DELAYED RELEASE
UsageORAL
Start Marketing Date20121101
Marketing Category NameANDA
Application NumberANDA201089
ManufacturerActavis Pharma, Inc.
Substance NameDICLOFENAC SODIUM; MISOPROSTOL
Strength75; 200
Strength Unitmg/1; ug/1
Pharmacy ClassesCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]

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