"57664-185-31" National Drug Code (NDC)

Promethazine Hydrochloride And Codeine Phosphate 118 mL in 1 BOTTLE (57664-185-31)
(Sun Pharmaceutical Industries, Inc.)

NDC Code57664-185-31
Package Description118 mL in 1 BOTTLE (57664-185-31)
Product NDC57664-185
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePromethazine Hydrochloride And Codeine Phosphate
Non-Proprietary NamePromethazine Hydrochloride And Codeine Phosphate
Dosage FormSYRUP
UsageORAL
Start Marketing Date20100317
Marketing Category NameANDA
Application NumberANDA090180
ManufacturerSun Pharmaceutical Industries, Inc.
Substance NamePROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
Strength6.25; 10
Strength Unitmg/5mL; mg/5mL
Pharmacy ClassesPhenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCV

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