"0378-5111-01" National Drug Code (NDC)

Hydralazine Hydrochloride 100 TABLET in 1 BOTTLE, PLASTIC (0378-5111-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-5111-01
Package Description100 TABLET in 1 BOTTLE, PLASTIC (0378-5111-01)
Product NDC0378-5111
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydralazine Hydrochloride
Non-Proprietary NameHydralazine Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20101213
Marketing Category NameANDA
Application NumberANDA090413
ManufacturerMylan Pharmaceuticals Inc.
Substance NameHYDRALAZINE HYDROCHLORIDE
Strength10
Strength Unitmg/1
Pharmacy ClassesArteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]

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