NDC 35356-802

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 Lake Erie Medical Dba Quality Care Product S Llc. The primary component is Oxycodone Hydrochloride; Acetaminophen.

Product ID35356-802_428059f2-0361-4b6b-8082-bf627053a9a0
NDC35356-802
Product TypeHuman Prescription Drug
Proprietary NameOxycodone and Acetaminophen
Generic NameOxycodone And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-08-02
Marketing CategoryANDA / ANDA
Application NumberANDA202677
Labeler NameLake Erie Medical DBA Quality Care Product s LLC
Substance NameOXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 35356-802-30

30 TABLET in 1 BOTTLE (35356-802-30)
Marketing Start Date2013-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-802-01 [35356080201]

Oxycodone and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA202677
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-10
Marketing End Date2019-10-11

NDC 35356-802-90 [35356080290]

Oxycodone and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA202677
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-10
Marketing End Date2019-10-11

NDC 35356-802-40 [35356080240]

Oxycodone and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA202677
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-10
Marketing End Date2019-10-11

NDC 35356-802-15 [35356080215]

Oxycodone and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA202677
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-10
Marketing End Date2019-10-11

NDC 35356-802-60 [35356080260]

Oxycodone and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA202677
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-10
Marketing End Date2019-10-11

NDC 35356-802-30 [35356080230]

Oxycodone and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA202677
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-10
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE7.5 mg/1

OpenFDA Data

SPL SET ID:bbbc5dc1-5a91-4430-adcb-a5f6963cc0a2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049214
  • 1049225
  • 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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