"64850-642-12" National Drug Code (NDC)

Acetaminophen And Codeine Phosphate 120 TABLET in 1 BOTTLE (64850-642-12)
(Elite Laboratories, Inc.)

NDC Code64850-642-12
Package Description120 TABLET in 1 BOTTLE (64850-642-12)
Product NDC64850-642
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAcetaminophen And Codeine Phosphate
Non-Proprietary NameAcetaminophen And Codeine Phosphate
Dosage FormTABLET
UsageORAL
Start Marketing Date20190910
Marketing Category NameANDA
Application NumberANDA212418
ManufacturerElite Laboratories, Inc.
Substance NameACETAMINOPHEN; CODEINE PHOSPHATE
Strength300; 30
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCIII

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