NDC 72245-681

Prolate

Oxycodone And Acetaminophen

Prolate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Forte Bio-pharma Llc. The primary component is Oxycodone Hydrochloride; Acetaminophen.

Product ID72245-681_9cbc4097-efc7-9042-e053-2995a90a060c
NDC72245-681
Product TypeHuman Prescription Drug
Proprietary NameProlate
Generic NameOxycodone And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-02-17
Marketing CategoryANDA / ANDA
Application NumberANDA040608
Labeler NameForte Bio-Pharma LLC
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 Through2021-12-31

Packaging

NDC 72245-681-03

30 TABLET in 1 BOTTLE, PLASTIC (72245-681-03)
Marketing Start Date2020-02-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72245-681-03 [72245068103]

Prolate TABLET
Marketing CategoryANDA
Application NumberANDA040608
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-17

NDC 72245-681-10 [72245068110]

Prolate TABLET
Marketing CategoryANDA
Application NumberANDA040608
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-17

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:9cbbfa94-37b9-9652-e053-2995a90a736b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014632
  • 1014615
  • 1014599
  • 2279514
  • 2279510
  • 2279512
    • UPC Code
  • 0372245683103
  • 0372245682106
  • 0372245681109

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Prolate" or generic name "Oxycodone And Acetaminophen"

    NDCBrand NameGeneric Name
    72245-681ProlateProlate
    72245-682ProlateProlate
    72245-683ProlateProlate
    72245-648ProlateProlate
    0054-0551Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0228-2981Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0228-2982Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0228-2983Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0527-1669Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0527-1671Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0904-7093OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophen
    0904-7094OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophen
    0904-7095OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophen
    10544-621Oxycodone and AcetaminophenOxycodone and Acetaminophen
    10702-184Oxycodone and AcetaminophenOxycodone and Acetaminophen
    10702-185Oxycodone and AcetaminophenOxycodone and Acetaminophen
    10702-186Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0054-3686RoxicetOxycodone and Acetaminophen
    0054-4650RoxicetOxycodone and Acetaminophen
    0054-8648RoxicetOxycodone and Acetaminophen
    0054-8650RoxicetOxycodone and Acetaminophen

    Trademark Results [Prolate]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROLATE
    PROLATE
    88695547 not registered Live/Pending
    Argent Development Group, LLC
    2019-11-17
    PROLATE
    PROLATE
    87035226 not registered Live/Pending
    Argent Development Group, LLC
    2016-05-12
    PROLATE
    PROLATE
    85773194 not registered Dead/Abandoned
    Argent Development Group, LLC
    2012-11-06
    PROLATE
    PROLATE
    72165639 0787384 Dead/Expired
    STAUFFER CHEMICAL COMPANY
    1963-03-28
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