NDC 13107-043

Oxycodone and Acetaminophen

Oxycodone And Acetaminophen

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

Product ID13107-043_42ad3383-08cd-4678-8b54-54366502f6e8
NDC13107-043
Product TypeHuman Prescription Drug
Proprietary NameOxycodone and Acetaminophen
Generic NameOxycodone And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-07-15
Marketing CategoryANDA / ANDA
Application NumberANDA201972
Labeler NameAurolife Pharma LLC
Substance NameOXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength3 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 13107-043-01

100 TABLET in 1 BOTTLE (13107-043-01)
Marketing Start Date2013-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13107-043-30 [13107004330]

Oxycodone and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA201972
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-07-15

NDC 13107-043-01 [13107004301]

Oxycodone and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA201972
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-07-15

NDC 13107-043-99 [13107004399]

Oxycodone and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA201972
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-07-15

NDC 13107-043-05 [13107004305]

Oxycodone and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA201972
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-07-15

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE2.5 mg/1

OpenFDA Data

SPL SET ID:69df20d9-b1d5-47dc-9ff0-29987284f8c7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049214
  • 1049221
  • 1049225
  • 1049635

    • Pharmacological Class

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

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