"53002-3270-1" National Drug Code (NDC)

Promethazine With Codeine 118 mL in 1 BOTTLE (53002-3270-1)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-3270-1
Package Description118 mL in 1 BOTTLE (53002-3270-1)
Product NDC53002-3270
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePromethazine With Codeine
Non-Proprietary NamePromethazine Hydrochloride And Codeine Phosphate
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20060131
Marketing Category NameANDA
Application NumberANDA040650
ManufacturerRPK Pharmaceuticals, Inc.
Substance NamePROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
Strength6.25; 10
Strength Unitmg/5mL; mg/5mL
Pharmacy ClassesPhenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCV

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