"65162-360-18" National Drug Code (NDC)

Mesalamine 180 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-360-18)
(Amneal Pharmaceuticals LLC)

NDC Code65162-360-18
Package Description180 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-360-18)
Product NDC65162-360
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMesalamine
Non-Proprietary NameMesalamine
Dosage FormTABLET, DELAYED RELEASE
UsageORAL
Start Marketing Date20250219
Marketing Category NameANDA
Application NumberANDA215067
ManufacturerAmneal Pharmaceuticals LLC
Substance NameMESALAMINE
Strength800
Strength Unitmg/1
Pharmacy ClassesAminosalicylate [EPC], Aminosalicylic Acids [CS]

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