"52959-118-04" National Drug Code (NDC)

Promethazine With Codeine 118 mL in 1 BOTTLE, PLASTIC (52959-118-04)
(H.J. Harkins Company,Inc.)

NDC Code52959-118-04
Package Description118 mL in 1 BOTTLE, PLASTIC (52959-118-04)
Product NDC52959-118
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePromethazine With Codeine
Non-Proprietary NamePromethazine Hydrochloride And Codeine Phosphate
Dosage FormSYRUP
UsageORAL
Start Marketing Date20151208
Marketing Category NameANDA
Application NumberANDA088875
ManufacturerH.J. Harkins Company,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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