NDC 0603-4998

Oxycodone and Acetaminophen

Oxycodone Hydrochloride And Acetaminophen

Oxycodone and Acetaminophen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical. The primary component is Oxycodone Hydrochloride; Acetaminophen.

Product ID0603-4998_c1fbefca-d9b4-47c4-a510-e93b0e6e3e1c
NDC0603-4998
Product TypeHuman Prescription Drug
Proprietary NameOxycodone and Acetaminophen
Generic NameOxycodone Hydrochloride And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1996-07-30
Marketing CategoryANDA / ANDA
Application NumberANDA040105
Labeler NamePar Pharmaceutical
Substance NameOXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0603-4998-21

100 TABLET in 1 BOTTLE, PLASTIC (0603-4998-21)
Marketing Start Date1996-07-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-4998-32 [00603499832]

Oxycodone and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040105
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-07-30
Marketing End Date2016-02-24

NDC 0603-4998-10 [00603499810]

Oxycodone and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040105
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-07-30
Marketing End Date2016-02-24

NDC 0603-4998-28 [00603499828]

Oxycodone and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040105
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-07-30

NDC 0603-4998-21 [00603499821]

Oxycodone and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA040105
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-07-30

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:0ffab497-1988-426b-8c9e-3be653a203dd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049221
    • UPC Code
  • 0306034998215

    • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "Oxycodone and Acetaminophen" or generic name "Oxycodone Hydrochloride And Acetaminophen"

    NDCBrand NameGeneric Name
    0054-0551Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0228-2981Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0228-2982Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0228-2983Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0406-0512OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    0406-0522OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    0406-0523OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    0527-1669Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0527-1671Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0603-4978Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    0603-4979Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    0603-4982Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    0603-4998Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    68084-355Oxycodone and AcetaminophenOxycodone and Acetaminophen
    68084-710Oxycodone and AcetaminophenOxycodone and Acetaminophen
    68094-013Oxycodone and AcetaminophenOxycodone and Acetaminophen
    68084-699Oxycodone and AcetaminophenOxycodone and Acetaminophen
    68308-480Oxycodone and AcetaminophenOxycodone and Acetaminophen
    68308-840Oxycodone and AcetaminophenOxycodone and Acetaminophen
    68308-842Oxycodone and AcetaminophenOxycodone and Acetaminophen
    68308-843Oxycodone and AcetaminophenOxycodone and Acetaminophen
    68308-405Oxycodone and AcetaminophenOxycodone and Acetaminophen
    68308-475Oxycodone and AcetaminophenOxycodone and Acetaminophen
    68308-841Oxycodone and AcetaminophenOxycodone and Acetaminophen
    70700-105Oxycodone and AcetaminophenOxycodone and Acetaminophen
    70710-1327Oxycodone and AcetaminophenOxycodone and Acetaminophen
    70710-1328Oxycodone and AcetaminophenOxycodone and Acetaminophen
    70710-1329Oxycodone and AcetaminophenOxycodone and Acetaminophen
    70710-1330Oxycodone and AcetaminophenOxycodone and Acetaminophen
    71335-0146Oxycodone and AcetaminophenOxycodone and Acetaminophen
    71335-0216Oxycodone and AcetaminophenOxycodone and Acetaminophen
    71335-0193Oxycodone and AcetaminophenOxycodone and Acetaminophen
    71335-0221oxycodone and acetaminophenoxycodone and acetaminophen
    71335-1036Oxycodone and AcetaminophenOxycodone and Acetaminophen
    71335-0316Oxycodone and AcetaminophenOxycodone and Acetaminophen
    71335-0722Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0904-6438Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0904-6439Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0904-6437Oxycodone and AcetaminophenOxycodone and Acetaminophen
    10544-287OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHEN
    10702-187Oxycodone and AcetaminophenOxycodone and Acetaminophen
    10544-621Oxycodone and AcetaminophenOxycodone and Acetaminophen
    10702-238OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHEN
    10702-185Oxycodone and AcetaminophenOxycodone and Acetaminophen
    10702-186Oxycodone and AcetaminophenOxycodone and Acetaminophen
    10702-184Oxycodone and AcetaminophenOxycodone and Acetaminophen
    13107-044Oxycodone and AcetaminophenOxycodone and Acetaminophen
    13107-043Oxycodone and AcetaminophenOxycodone and Acetaminophen
    12634-942Oxycodone and AcetaminophenOxycodone and Acetaminophen
    13107-045Oxycodone and AcetaminophenOxycodone and Acetaminophen
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.