"0378-7401-78" National Drug Code (NDC)

Mesalamine 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-7401-78)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-7401-78
Package Description120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-7401-78)
Product NDC0378-7401
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMesalamine
Non-Proprietary NameMesalamine Film Coated
Dosage FormTABLET, DELAYED RELEASE
UsageORAL
Start Marketing Date20181214
Marketing Category NameANDA
Application NumberANDA203574
ManufacturerMylan Pharmaceuticals Inc.
Substance NameMESALAMINE
Strength1.2
Strength Unitg/1
Pharmacy ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]

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