NDC 72245-193

Nalocet

Oxycodone And Acetaminophen

Nalocet 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 ID72245-193_7ba5b89a-5035-264e-e053-2991aa0ad5bf
NDC72245-193
Product TypeHuman Prescription Drug
Proprietary NameNalocet
Generic NameOxycodone And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-05-23
Marketing CategoryANDA / ANDA
Application NumberANDA040608
Labeler NameForte Bio-Pharma LLC
Substance NameOXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength3 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72245-193-03

30 TABLET in 1 BOTTLE, PLASTIC (72245-193-03)
Marketing Start Date2018-05-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72245-193-03 [72245019303]

Nalocet TABLET
Marketing CategoryANDA
Application NumberANDA040608
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-23

NDC 72245-193-10 [72245019310]

Nalocet TABLET
Marketing CategoryANDA
Application NumberANDA040608
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-23

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE2.5 mg/1

OpenFDA Data

SPL SET ID:f5f7dfca-a5c7-4445-8a5e-9ec62f33f5be
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1037259
  • 2045500
    • UPC Code
  • 0372245193107

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    72245-193NalocetNalocet
    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 [Nalocet]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NALOCET
    NALOCET
    87502293 5571641 Live/Registered
    Argent Development Group, LLC
    2017-06-23
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