"0378-2022-05" National Drug Code (NDC)

Irbesartan 500 TABLET in 1 BOTTLE, PLASTIC (0378-2022-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-2022-05
Package Description500 TABLET in 1 BOTTLE, PLASTIC (0378-2022-05)
Product NDC0378-2022
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIrbesartan
Non-Proprietary NameIrbesartan
Dosage FormTABLET
UsageORAL
Start Marketing Date20120928
Marketing Category NameANDA
Application NumberANDA200461
ManufacturerMylan Pharmaceuticals Inc.
Substance NameIRBESARTAN
Strength75
Strength Unitmg/1
Pharmacy ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]

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