"0378-0355-05" National Drug Code (NDC)

Diclofenac Sodium 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0355-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-0355-05
Package Description500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0355-05)
Product NDC0378-0355
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDiclofenac Sodium
Non-Proprietary NameDiclofenac Sodium
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20020215
Marketing Category NameANDA
Application NumberANDA076152
ManufacturerMylan Pharmaceuticals Inc.
Substance NameDICLOFENAC SODIUM
Strength100
Strength Unitmg/1
Pharmacy ClassesCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]

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