NDC 69344-201

Tivorbex

Indomethacin

Tivorbex is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Egalet Us Inc.. The primary component is Indomethacin.

Product ID69344-201_6d48a6bc-af86-4501-8855-a5bcbe6061cd
NDC69344-201
Product TypeHuman Prescription Drug
Proprietary NameTivorbex
Generic NameIndomethacin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-02-04
Marketing CategoryNDA / NDA
Application NumberNDA204768
Labeler NameEgalet US Inc.
Substance NameINDOMETHACIN
Active Ingredient Strength20 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69344-201-29

90 CAPSULE in 1 BOTTLE (69344-201-29)
Marketing Start Date2019-02-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69344-201-29 [69344020129]

Tivorbex CAPSULE
Marketing CategoryNDA
Application NumberNDA204768
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-04

Drug Details

Active Ingredients

IngredientStrength
INDOMETHACIN20 mg/1

OpenFDA Data

SPL SET ID:cd2e42ae-4b30-404e-a2aa-1892420b1b57
Manufacturer
UNII
PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0369344201291
  • 0369344202298
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Cyclooxygenase Inhibitors [MoA]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    NDC Crossover Matching brand name "Tivorbex" or generic name "Indomethacin"

    NDCBrand NameGeneric Name
    42211-201Tivorbexindomethacin
    42211-202Tivorbexindomethacin
    69344-201TivorbexTivorbex
    69344-202TivorbexTivorbex
    69597-350TivorbexTivorbex
    42211-101INDOCINindomethacin
    42211-102INDOCINIndomethacin
    0185-0720IndomethacinIndomethacin
    0378-0143Indomethacinindomethacin
    0378-0147Indomethacinindomethacin
    0409-1113IndomethacinIndomethacin
    0440-1652Indomethacinindomethacin
    0713-0176INDOMETHACININDOMETHACIN
    10544-083IndomethacinIndomethacin
    10544-216Indomethacinindomethacin
    10544-234Indomethacinindomethacin
    10544-919IndomethacinIndomethacin
    10544-935IndomethacinIndomethacin
    10702-016INDOMETHACINIndomethacin
    21695-522IndomethacinIndomethacin
    21695-523IndomethacinIndomethacin
    23155-010IndomethacinIndomethacin
    23155-011IndomethacinIndomethacin
    31722-542IndomethacinIndomethacin
    31722-543IndomethacinIndomethacin
    31722-565IndomethacinIndomethacin
    33261-133Indomethacinindomethacin
    35356-697IndomethacinIndomethacin
    42254-081IndomethacinIndomethacin
    42254-237INDOMETHACINindomethacin
    42708-030indomethacinindomethacin
    43063-368IndomethacinIndomethacin
    12634-160INDOMETHACIN ERINDOMETHACIN
    12634-838INDOMETHACIN ERINDOMETHACIN

    Trademark Results [Tivorbex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TIVORBEX
    TIVORBEX
    86088781 4721033 Live/Registered
    GENUS LIFESCIENCES INC.
    2013-10-10
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