"42549-538-12" National Drug Code (NDC)

Ketotolac Tromethamine 12 TABLET, FILM COATED in 1 BOTTLE (42549-538-12)
(STAT Rx USA LLC)

NDC Code42549-538-12
Package Description12 TABLET, FILM COATED in 1 BOTTLE (42549-538-12)
Product NDC42549-538
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameKetotolac Tromethamine
Non-Proprietary NameKetotolac Tromethamine
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20100915
Marketing Category NameANDA
Application NumberANDA074761
ManufacturerSTAT Rx USA LLC
Substance NameKETOROLAC TROMETHAMINE
Strength10
Strength Unitmg/1
Pharmacy ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]

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