"10135-495-10" National Drug Code (NDC)

Promethazine Hydrochloride 1000 TABLET in 1 BOTTLE (10135-495-10)
(Marlex Pharmaceuticals Inc)

NDC Code10135-495-10
Package Description1000 TABLET in 1 BOTTLE (10135-495-10)
Product NDC10135-495
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePromethazine Hydrochloride
Non-Proprietary NamePromethazine Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20161001
Marketing Category NameANDA
Application NumberANDA091179
ManufacturerMarlex Pharmaceuticals Inc
Substance NamePROMETHAZINE HYDROCHLORIDE
Strength25
Strength Unitmg/1
Pharmacy ClassesPhenothiazine [EPC], Phenothiazines [CS]

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