NDC 11584-0030

Tencon

Butalbital And Acetaminophen

Tencon is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by International Ethical Labs, Inc.. The primary component is Butalbital; Acetaminophen.

Product ID11584-0030_7b9739a3-9ce9-d310-e053-2a91aa0ad4a6
NDC11584-0030
Product TypeHuman Prescription Drug
Proprietary NameTencon
Generic NameButalbital And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-10-10
Marketing CategoryANDA / ANDA
Application NumberANDA089987
Labeler NameInternational Ethical Labs, Inc.
Substance NameBUTALBITAL; ACETAMINOPHEN
Active Ingredient Strength50 mg/1; mg/1
Pharm ClassesBarbiturates [CS],Barbiturate [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 11584-0030-1

100 TABLET in 1 BOTTLE, PLASTIC (11584-0030-1)
Marketing Start Date2013-10-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11584-0030-1 [11584003001]

Tencon TABLET
Marketing CategoryANDA
Application NumberANDA089987
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-10-10
Inactivation Date2020-01-31
Reactivation Date2020-02-18

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:4e4a9925-67aa-4be7-8bb7-c8b058ffe223
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1483329
  • 197426
  • UPC Code
  • 0311584003012
  • Pharmacological Class

    • Barbiturates [CS]
    • Barbiturate [EPC]

    NDC Crossover Matching brand name "Tencon" or generic name "Butalbital And Acetaminophen"

    NDCBrand NameGeneric Name
    11584-0030Tenconbutalbital and acetaminophen
    68047-752Allzitalbutalbital and acetaminophen
    0603-2540butalbital and acetaminophenbutalbital and acetaminophen
    0722-7075Butalbital and AcetaminophenButalbital and Acetaminophen
    35573-455BUTALBITAL AND ACETAMINOPHENbutalbital and acetaminophen
    35573-456BUTALBITAL AND ACETAMINOPHENbutalbital and acetaminophen
    46672-856butalbital and acetaminophenbutalbital and acetaminophen
    47781-534butalbital and acetaminophenbutalbital and acetaminophen
    47781-535Butalbital and AcetaminophenButalbital and Acetaminophen
    47781-628Butalbital and AcetaminophenButalbital and Acetaminophen
    47781-644butalbital and acetaminophenbutalbital and acetaminophen
    51862-538butalbital and acetaminophenbutalbital and acetaminophen
    51862-544butalbital and acetaminophenbutalbital and acetaminophen
    54879-026Butalbital And Acetaminophenbutalbital and acetaminophen
    68047-721Butalbital And Acetaminophenbutalbital and acetaminophen
    68047-722butalbital and acetaminophenbutalbital and acetaminophen
    46672-099Butapapbutalbital and acetaminophen

    Trademark Results [Tencon]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TENCON
    TENCON
    85770015 4387075 Live/Registered
    APPLIED SYSTEMS CLIENT NETWORK, INC. NFP
    2012-11-02
    TENCON
    TENCON
    85769907 4387073 Live/Registered
    APPLIED SYSTEMS CLIENT NETWORK, INC. NFP
    2012-11-02
    TENCON
    TENCON
    78105737 2652072 Live/Registered
    International Ethical Labs., Inc.
    2002-01-30
    TENCON
    TENCON
    74246166 1742696 Dead/Cancelled
    INTERNATIONAL ETHICAL LABS, INC.
    1992-02-12
    TENCON
    TENCON
    73694476 1524229 Dead/Cancelled
    PLASTI-LINE MANUFACTURING COMPANY
    1987-11-09

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