"80425-0273-1" National Drug Code (NDC)

Dicloenac Sodium And Misoprostol 60 TABLET in 1 BOTTLE (80425-0273-1)
(Advanced Rx Pharmacy of Tennessee, LLC)

NDC Code80425-0273-1
Package Description60 TABLET in 1 BOTTLE (80425-0273-1)
Product NDC80425-0273
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDicloenac Sodium And Misoprostol
Proprietary Name SuffixDr
Non-Proprietary NameDicloenac Sodium And Misoprostol
Dosage FormTABLET
UsageORAL
Start Marketing Date20230216
Marketing Category NameANDA
Application NumberANDA204355
ManufacturerAdvanced Rx Pharmacy of Tennessee, 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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