"68382-435-28" National Drug Code (NDC)

Mesalamine 180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-435-28
Package Description180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28)
Product NDC68382-435
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMesalamine
Non-Proprietary NameMesalamine
Dosage FormTABLET, DELAYED RELEASE
UsageORAL
Start Marketing Date20180802
Marketing Category NameANDA
Application NumberANDA203286
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameMESALAMINE
Strength800
Strength Unitmg/1
Pharmacy ClassesAminosalicylate [EPC], Aminosalicylic Acids [CS]

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