NDC 54092-191

Pentasa

Mesalamine

Pentasa is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Mesalamine.

Product ID54092-191_642f21aa-73bf-4414-afb7-e29c879c1600
NDC54092-191
Product TypeHuman Prescription Drug
Proprietary NamePentasa
Generic NameMesalamine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2004-07-08
Marketing CategoryNDA / NDA
Application NumberNDA020049
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NameMESALAMINE
Active Ingredient Strength500 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 54092-191-12

120 CAPSULE in 1 BOTTLE (54092-191-12)
Marketing Start Date2004-07-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54092-191-08 [54092019108]

Pentasa CAPSULE
Marketing CategoryNDA
Application NumberNDA020049
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-07-08

NDC 54092-191-12 [54092019112]

Pentasa CAPSULE
Marketing CategoryNDA
Application NumberNDA020049
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-07-08

NDC 54092-191-80 [54092019180]

Pentasa CAPSULE
Marketing CategoryNDA
Application NumberNDA020049
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-07-08
Marketing End Date2010-03-17

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE500 mg/1

OpenFDA Data

SPL SET ID:e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 476362
  • 314092
  • 580286
  • 206791
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

    Medicade Reported Pricing

    54092019112 PENTASA 500 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Pentasa" or generic name "Mesalamine"

    NDCBrand NameGeneric Name
    68151-4769PentasaPentasa
    69189-0189PentasaPentasa
    54092-189PentasaPentasa
    54092-191PentasaPentasa
    0023-5901Asacol HDmesalamine
    0430-0783ASACOL HDmesalamine
    0023-5853Delzicolmesalamine
    0179-0142Lialdamesalamine
    0093-5907MesalamineMesalamine
    0093-9224mesalaminemesalamine
    0378-1375Mesalaminemesalamine
    0378-9230Mesalaminemesalamine
    0472-1915MesalamineMesalamine
    0037-0066Rowasamesalamine
    0037-0022sfRowasamesalamine

    Trademark Results [Pentasa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PENTASA
    PENTASA
    76705752 4007879 Live/Registered
    Ferring B.V.
    2010-12-22
    PENTASA
    PENTASA
    73365906 1279563 Live/Registered
    Farmaceutisk Laboratorium Ferring A/S
    1982-05-21

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