NDC 21695-143

ULTRACET

Tramadol Hydrochloride And Acetaminophen

ULTRACET is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Tramadol Hydrochloride; Acetaminophen.

Product ID21695-143_750e7372-022b-454e-86c4-e4b325fb9f42
NDC21695-143
Product TypeHuman Prescription Drug
Proprietary NameULTRACET
Generic NameTramadol Hydrochloride And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2001-08-15
Marketing CategoryNDA / NDA
Application NumberNDA021123
Labeler NameRebel Distributors Corp
Substance NameTRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength38 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-143-72

120 TABLET in 1 BOTTLE (21695-143-72)
Marketing Start Date2001-08-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-143-72 [21695014372]

ULTRACET TABLET
Marketing CategoryNDA
Application NumberNDA021123
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-08-15
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE37.5 mg/1

OpenFDA Data

SPL SET ID:750e7372-022b-454e-86c4-e4b325fb9f42
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 836397
  • 836395

    • Pharmacological Class

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

    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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