NDC 46672-648

oxycodone hydrochloride and acetaminophen

Oxycodone Hydrochloride And Acetaminophen

oxycodone hydrochloride and acetaminophen is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Mikart, Llc. The primary component is Oxycodone Hydrochloride; Acetaminophen.

Product ID46672-648_95079003-8613-467f-e053-2995a90a3afc
NDC46672-648
Product TypeHuman Prescription Drug
Proprietary Nameoxycodone hydrochloride and acetaminophen
Generic NameOxycodone Hydrochloride And Acetaminophen
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-03-20
Marketing CategoryANDA / ANDA
Application NumberANDA202142
Labeler NameMikart, LLC
Substance NameOXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength10 mg/5mL; mg/5mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 46672-648-55

500 mL in 1 BOTTLE, PLASTIC (46672-648-55)
Marketing Start Date2018-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46672-648-04 [46672064804]

oxycodone hydrochloride and acetaminophen SOLUTION
Marketing CategoryANDA
Application NumberANDA202142
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-01

NDC 46672-648-55 [46672064855]

oxycodone hydrochloride and acetaminophen SOLUTION
Marketing CategoryANDA
Application NumberANDA202142
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-20

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE10 mg/5mL

OpenFDA Data

SPL SET ID:483e7cd1-5d70-4d83-8846-df791f73a97a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2105822
    • UPC Code
  • 0346672648554

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    29033-405Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and Acetaminophen
    46672-648oxycodone hydrochloride and acetaminophenoxycodone hydrochloride and acetaminophen
    60760-200Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and Acetaminophen
    64850-622Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and Acetaminophen
    64850-623Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and Acetaminophen
    64850-621Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and Acetaminophen
    72887-648oxycodone hydrochloride and acetaminophenoxycodone hydrochloride and acetaminophen
    0406-0512OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    0406-0522OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    0406-0523OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride 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
    0904-6437Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    0904-6438Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    0904-6439Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    10544-287OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    21695-233OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    21695-616Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    52959-556Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    55700-983OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    55700-984OXYCODONE AND ACETAMINOPHENoxycodone hydrochloride and acetaminophen
    63187-406Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen
    63481-623PERCOCEToxycodone hydrochloride and acetaminophen
    63481-627PERCOCEToxycodone hydrochloride and acetaminophen
    23635-115Xartemisoxycodone hydrochloride and acetaminophen
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