NDC 75987-010

DUEXIS

Ibuprofen And Famotidine

DUEXIS is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Horizon Therapeutics Usa, Inc.. The primary component is Ibuprofen; Famotidine.

Product ID75987-010_66e942ac-f015-4c57-a99d-4cb7ace0450b
NDC75987-010
Product TypeHuman Prescription Drug
Proprietary NameDUEXIS
Generic NameIbuprofen And Famotidine
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2011-12-05
Marketing CategoryNDA / NDA
Application NumberNDA022519
Labeler NameHorizon Therapeutics USA, Inc.
Substance NameIBUPROFEN; FAMOTIDINE
Active Ingredient Strength800 mg/1; mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 75987-010-03

90 TABLET, COATED in 1 BOTTLE (75987-010-03)
Marketing Start Date2011-12-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75987-010-03 [75987001003]

DUEXIS TABLET, COATED
Marketing CategoryNDA
Application NumberNDA022519
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-12-05

NDC 75987-010-71 [75987001071]

DUEXIS TABLET, COATED
Marketing CategoryNDA
Application NumberNDA022519
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-11-17
Marketing End Date2015-07-27

NDC 75987-010-72 [75987001072]

DUEXIS TABLET, COATED
Marketing CategoryNDA
Application NumberNDA022519
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-12-05

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN800 mg/1

OpenFDA Data

SPL SET ID:558b9f26-37b2-423b-932d-25a37afe57ec
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1100070
  • 1100066
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Histamine H2 Receptor Antagonists [MoA]
    • Histamine-2 Receptor Antagonist [EPC]

    Medicade Reported Pricing

    75987001003 DUEXIS 800-26.6 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "DUEXIS" or generic name "Ibuprofen And Famotidine"

    NDCBrand NameGeneric Name
    75987-010DUEXISIbuprofen and Famotidine
    0093-8107Ibuprofen and famotidineIbuprofen and famotidine
    63629-8891Ibuprofen and famotidineIbuprofen and famotidine
    67877-626Ibuprofen and famotidineIbuprofen and famotidine
    69306-266Ibuprofen and famotidineIbuprofen and famotidine
    70748-312Ibuprofen and FamotidineIbuprofen and Famotidine

    Trademark Results [DUEXIS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DUEXIS
    DUEXIS
    77531168 3764313 Live/Registered
    HORIZON MEDICINES LLC
    2008-07-25

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