NDC 50458-650

ULTRACET

Tramadol Hydrochloride And Acetaminophen

ULTRACET is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Acetaminophen; Tramadol Hydrochloride.

Product ID50458-650_235c1654-b6a3-11ec-bf4b-c8035e6d7a1b
NDC50458-650
Product TypeHuman Prescription Drug
Proprietary NameULTRACET
Generic NameTramadol Hydrochloride And Acetaminophen
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2001-08-15
Marketing CategoryNDA / NDA
Application NumberNDA021123
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50458-650-60

100 TABLET, COATED in 1 BOTTLE (50458-650-60)
Marketing Start Date2001-08-15
Marketing End Date2022-10-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-650-60 [50458065060]

ULTRACET TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021123
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-08-15

NDC 50458-650-10 [50458065010]

ULTRACET TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021123
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-08-15

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE37.5 mg/1

OpenFDA Data

SPL SET ID:2d20df3c-8b5b-4bdf-a49f-ec904522575d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 836397
  • 836395
    • UPC Code
  • 0350458650600

    • Pharmacological Class

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

    Medicade Reported Pricing

    50458065060 ULTRACET TABLET

    Pricing Unit: EA | Drug Type:

    50458065010 ULTRACET TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "ULTRACET" or generic name "Tramadol Hydrochloride And Acetaminophen"

    NDCBrand NameGeneric Name
    21695-143ULTRACETtramadol hydrochloride and acetaminophen
    50458-650ULTRACETtramadol hydrochloride and acetaminophen
    0378-8088Tramadol Hydrochloride and Acetaminophentramadol hydrochloride and acetaminophen
    21695-236Tramadol Hydrochloride and Acetaminophentramadol hydrochloride and acetaminophen
    33261-389Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    33342-202Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    33358-343Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    42254-051Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    42291-832Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    42571-119TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
    45865-469Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    49884-946Tramadol hydrochloride and acetaminophentramadol hydrochloride and acetaminophen
    50090-0919Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    50090-3248Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    50090-3705TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
    50268-774Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    50436-6291Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    52959-814TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
    53217-040Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    53217-180Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    53746-617Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    55700-124Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen
    57664-537TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

    Trademark Results [ULTRACET]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ULTRACET
    ULTRACET
    75934730 2689692 Dead/Cancelled
    JOHNSON & JOHNSON
    2000-03-03
    ULTRACET
    ULTRACET
    75578901 2694319 Live/Registered
    Johnson & Johnson
    1998-10-29
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