"80425-0528-3" National Drug Code (NDC)

Acetaminophen And Codeine Phosphate 90 TABLET in 1 BOTTLE (80425-0528-3)
(Advanced Rx of Tennessee, LLC)

NDC Code80425-0528-3
Package Description90 TABLET in 1 BOTTLE (80425-0528-3)
Product NDC80425-0528
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAcetaminophen And Codeine Phosphate
Non-Proprietary NameAcetaminophen And Codeine Phosphate
Dosage FormTABLET
UsageORAL
Start Marketing Date20250602
Marketing Category NameANDA
Application NumberANDA089828
ManufacturerAdvanced Rx of Tennessee, LLC
Substance NameACETAMINOPHEN; CODEINE PHOSPHATE
Strength300; 60
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCIII

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