NDC 64850-621

Oxycodone Hydrochloride and Acetaminophen

Oxycodone Hydrochloride And Acetaminophen

Oxycodone Hydrochloride and Acetaminophen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Elite Laboratories, Inc.. The primary component is Oxycodone Hydrochloride; Acetaminophen.

Product ID64850-621_062005aa-b8a5-4c22-a7f2-827684906675
NDC64850-621
Product TypeHuman Prescription Drug
Proprietary NameOxycodone Hydrochloride and Acetaminophen
Generic NameOxycodone Hydrochloride And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-12-04
Marketing CategoryANDA / ANDA
Application NumberANDA209385
Labeler NameElite Laboratories, Inc.
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 Through2020-12-31

Packaging

NDC 64850-621-90

90 TABLET in 1 BOTTLE (64850-621-90)
Marketing Start Date2017-12-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64850-621-90 [64850062190]

Oxycodone Hydrochloride and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA209385
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-04
Marketing End Date2019-12-10

NDC 64850-621-60 [64850062160]

Oxycodone Hydrochloride and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA209385
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-04
Marketing End Date2019-12-10

NDC 64850-621-30 [64850062130]

Oxycodone Hydrochloride and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA209385
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-04
Marketing End Date2019-12-10

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:27fa8190-d334-4bb9-b277-d1f44db433e3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049214
  • 1049221
  • 1049225
    • UPC Code
  • 0364850623308
  • 0364850622301
  • 0364850621304

    • 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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