"68382-800-05" National Drug Code (NDC)

Labetalol Hydrochloride 500 TABLET, FILM COATED in 1 BOTTLE (68382-800-05)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-800-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE (68382-800-05)
Product NDC68382-800
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameLabetalol Hydrochloride
Non-Proprietary NameLabetalol Hydrochloride
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20171205
Marketing Category NameANDA
Application NumberANDA207743
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameLABETALOL HYDROCHLORIDE
Strength300
Strength Unitmg/1
Pharmacy ClassesAdrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]

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