NDC 68151-4769

Pentasa

Mesalamine

Pentasa is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Carilion Materials Management. The primary component is Mesalamine.

Product ID68151-4769_7eba11c1-f784-4bf4-b66f-c3f66fd634c9
NDC68151-4769
Product TypeHuman Prescription Drug
Proprietary NamePentasa
Generic NameMesalamine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1993-05-10
Marketing CategoryNDA / NDA
Application NumberNDA020049
Labeler NameCarilion Materials Management
Substance NameMESALAMINE
Active Ingredient Strength250 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68151-4769-8

1 CAPSULE in 1 PACKAGE (68151-4769-8)
Marketing Start Date1993-05-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68151-4769-8 [68151476908]

Pentasa CAPSULE
Marketing CategoryNDA
Application NumberNDA020049
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1993-05-10
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE250 mg/1

OpenFDA Data

SPL SET ID:ec53b1d4-b98d-4b4d-acc3-199f98031966
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314092
  • 206791
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

    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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