"68382-040-05" National Drug Code (NDC)

Promethazine Hydrochloride 500 TABLET in 1 BOTTLE (68382-040-05)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-040-05
Package Description500 TABLET in 1 BOTTLE (68382-040-05)
Product NDC68382-040
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePromethazine Hydrochloride
Non-Proprietary NamePromethazine Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20051214
Marketing Category NameANDA
Application NumberANDA040596
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NamePROMETHAZINE HYDROCHLORIDE
Strength12.5
Strength Unitmg/1
Pharmacy ClassesPhenothiazine [EPC], Phenothiazines [CS]

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