"42677-305-01" National Drug Code (NDC)

Isosorbide Mononitrate 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42677-305-01)
(Shandong New Time Pharmaceutical Co., Ltd.)

NDC Code42677-305-01
Package Description60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42677-305-01)
Product NDC42677-305
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIsosorbide Mononitrate
Non-Proprietary NameIsosorbide Mononitrate
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20240208
Marketing Category NameANDA
Application NumberANDA214115
ManufacturerShandong New Time Pharmaceutical Co., Ltd.
Substance NameISOSORBIDE MONONITRATE
Strength30
Strength Unitmg/1
Pharmacy ClassesNitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]

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