"68382-301-10" National Drug Code (NDC)

Irbesartan 1000 TABLET in 1 BOTTLE (68382-301-10)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-301-10
Package Description1000 TABLET in 1 BOTTLE (68382-301-10)
Product NDC68382-301
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIrbesartan
Non-Proprietary NameIrbesartan
Dosage FormTABLET
UsageORAL
Start Marketing Date20171208
Marketing Category NameANDA
Application NumberANDA079213
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameIRBESARTAN
Strength300
Strength Unitmg/1
Pharmacy ClassesAngiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]

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