"64679-215-01" National Drug Code (NDC)

Diclofenac Sodium And Misoprostol 30 TABLET, DELAYED RELEASE in 1 BOTTLE (64679-215-01)
(Wockhardt USA LLC.)

NDC Code64679-215-01
Package Description30 TABLET, DELAYED RELEASE in 1 BOTTLE (64679-215-01)
Product NDC64679-215
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDiclofenac Sodium And Misoprostol
Non-Proprietary NameDiclofenac Sodium And Misoprostol
Dosage FormTABLET, DELAYED RELEASE
UsageORAL
Start Marketing Date20120815
Marketing Category NameANDA
Application NumberANDA201948
ManufacturerWockhardt USA LLC.
Substance NameDICLOFENAC SODIUM; MISOPROSTOL
Strength50; .2
Strength Unitmg/1; mg/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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