"69654-480-01" National Drug Code (NDC)

Tuzistra Xr 473 mL in 1 BOTTLE (69654-480-01)
(Aytu BioPharma, Inc.)

NDC Code69654-480-01
Package Description473 mL in 1 BOTTLE (69654-480-01)
Product NDC69654-480
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTuzistra Xr
Non-Proprietary NameCodeine Polistirex And Chlorpheniramine Polistirex
Dosage FormSUSPENSION, EXTENDED RELEASE
UsageORAL
Start Marketing Date20150531
Marketing Category NameNDA
Application NumberNDA207768
ManufacturerAytu BioPharma, Inc.
Substance NameCHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE ANHYDROUS
Strength2.8; 14.7
Strength Unitmg/5mL; mg/5mL
Pharmacy ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA ScheduleCIII

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