"17856-0139-1" National Drug Code (NDC)

Promethazine Hydrochloride And Codeine Phosphate 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0139-1) > 5 mL in 1 CUP, UNIT-DOSE
(ATLANTIC BIOLOGICALS CORP.)

NDC Code17856-0139-1
Package Description72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0139-1) > 5 mL in 1 CUP, UNIT-DOSE
Product NDC17856-0139
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePromethazine Hydrochloride And Codeine Phosphate
Non-Proprietary NamePromethazine Hydrochloride And Codeine Phosphate
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20201008
Marketing Category NameANDA
Application NumberANDA214238
ManufacturerATLANTIC BIOLOGICALS CORP.
Substance NameCODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Strength10; 6.25
Strength Unitmg/5mL; mg/5mL
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]
DEA ScheduleCV

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