NDC 72245-648

Prolate

Oxycodone Hydrochloride And Acetaminophen

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

Product ID72245-648_9d75ad3b-bc9f-0c22-e053-2a95a90ac71e
NDC72245-648
Product TypeHuman Prescription Drug
Proprietary NameProlate
Generic NameOxycodone Hydrochloride And Acetaminophen
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2020-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA202142
Labeler NameForte Bio-Pharma 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 Through2021-12-31

Packaging

NDC 72245-648-12

120 mL in 1 BOTTLE, PLASTIC (72245-648-12)
Marketing Start Date2020-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72245-648-12 [72245064812]

Prolate SOLUTION
Marketing CategoryANDA
Application NumberANDA202142
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-01

NDC 72245-648-50 [72245064850]

Prolate SOLUTION
Marketing CategoryANDA
Application NumberANDA202142
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-01

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE10 mg/5mL

OpenFDA Data

SPL SET ID:9d75ad3b-bc9b-0c22-e053-2a95a90ac71e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2105822
  • 2281851
    • UPC Code
  • 0372245648126

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    72245-681ProlateProlate
    72245-682ProlateProlate
    72245-683ProlateProlate
    72245-648ProlateProlate
    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
    29033-405Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and Acetaminophen
    46672-648oxycodone hydrochloride and acetaminophenoxycodone hydrochloride and acetaminophen
    60760-200Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and Acetaminophen
    63481-623PERCOCEToxycodone hydrochloride and acetaminophen
    63481-627PERCOCEToxycodone hydrochloride and acetaminophen
    23635-115Xartemisoxycodone hydrochloride 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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