NDC 55154-5154

Dexilant

Dexlansoprazole

Dexilant is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Cardinal Health. The primary component is Dexlansoprazole.

Product ID55154-5154_48eb52d9-8e6b-48aa-8e66-f4815652d625
NDC55154-5154
Product TypeHuman Prescription Drug
Proprietary NameDexilant
Generic NameDexlansoprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2010-04-12
Marketing CategoryNDA / NDA
Application NumberNDA022287
Labeler NameCardinal Health
Substance NameDEXLANSOPRAZOLE
Active Ingredient Strength60 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55154-5154-8

1800 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55154-5154-8)
Marketing Start Date2010-04-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55154-5154-8 [55154515408]

Dexilant CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022287
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-04-12

NDC 55154-5154-2 [55154515402]

Dexilant CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022287
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-04-12
Marketing End Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
DEXLANSOPRAZOLE60 mg/1

OpenFDA Data

SPL SET ID:8a957692-7f20-4752-b29a-53cff9325dd2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 833213
  • 902626
  • UPC Code
  • 0355154515482
  • Pharmacological Class

    • Proton Pump Inhibitor [EPC]
    • Proton Pump Inhibitors [MoA]

    NDC Crossover Matching brand name "Dexilant" or generic name "Dexlansoprazole"

    NDCBrand NameGeneric Name
    50090-4374Dexilantdexlansoprazole
    55154-5154Dexilantdexlansoprazole
    64764-171Dexilantdexlansoprazole
    64764-175Dexilantdexlansoprazole
    24979-001Dexlansoprazoledexlansoprazole
    24979-002Dexlansoprazoledexlansoprazole
    24979-703Dexlansoprazoledexlansoprazole
    24979-704Dexlansoprazoledexlansoprazole
    49884-148DexlansoprazoleDexlansoprazole
    50090-5944Dexlansoprazoledexlansoprazole
    50090-5956Dexlansoprazoledexlansoprazole

    Trademark Results [Dexilant]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DEXILANT
    DEXILANT
    77946349 3887990 Live/Registered
    TAKEDA PHARMACEUTICALS U.S.A., INC.
    2010-02-26
    DEXILANT
    DEXILANT
    77946331 3887989 Live/Registered
    TAKEDA PHARMACEUTICALS U.S.A., INC.
    2010-02-26

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