"0378-1375-78" National Drug Code (NDC)

Mesalamine 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1375-78)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-1375-78
Package Description120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1375-78)
Product NDC0378-1375
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMesalamine
Non-Proprietary NameMesalamine
Dosage FormCAPSULE, EXTENDED RELEASE
UsageORAL
Start Marketing Date20191126
Marketing Category NameANDA
Application NumberANDA207271
ManufacturerMylan Pharmaceuticals Inc.
Substance NameMESALAMINE
Strength.375
Strength Unitg/1
Pharmacy ClassesAminosalicylate [EPC], Aminosalicylic Acids [CS]

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