NDC 68992-3040

Envarsus XR

Tacrolimus

Envarsus XR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Veloxis Pharmaceuticals, Inc. The primary component is Tacrolimus.

Product ID68992-3040_123aa480-0d98-46dc-8c45-7f528c6d3a06
NDC68992-3040
Product TypeHuman Prescription Drug
Proprietary NameEnvarsus XR
Generic NameTacrolimus
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-09-01
Marketing CategoryNDA / NDA
Application NumberNDA206406
Labeler NameVeloxis Pharmaceuticals, Inc
Substance NameTACROLIMUS
Active Ingredient Strength4 mg/1
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68992-3040-1

1 POUCH in 1 CARTON (68992-3040-1) > 1 BOTTLE in 1 POUCH > 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2015-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68992-3040-1 [68992304001]

Envarsus XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA206406
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-01

NDC 68992-3040-3 [68992304003]

Envarsus XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA206406
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-01

Drug Details

Active Ingredients

IngredientStrength
TACROLIMUS4 mg/1

OpenFDA Data

SPL SET ID:de2315b0-6344-43ac-9aea-3e3b68d828e7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1664434
  • 1664461
  • 1664463
  • 1664458
  • 1664440
  • 1664456
  • UPC Code
  • 0368992304019
  • 0368992307515
  • 0368992301018
  • 0368992304033
  • 0368992307539
  • 0368992301032
  • Pharmacological Class

    • Calcineurin Inhibitor Immunosuppressant [EPC]
    • Calcineurin Inhibitors [MoA]

    NDC Crossover Matching brand name "Envarsus XR" or generic name "Tacrolimus"

    NDCBrand NameGeneric Name
    68992-3010Envarsus XREnvarsus XR
    68992-3075Envarsus XREnvarsus XR
    68992-3040Envarsus XREnvarsus XR
    0469-0607PrografTacrolimus
    0469-0617PrografTacrolimus
    0469-0657PrografTacrolimus
    0093-3428Tacrolimustacrolimus
    0093-3429Tacrolimustacrolimus
    0168-0416Tacrolimustacrolimus
    0168-0417Tacrolimustacrolimus
    0378-2045TacrolimusTacrolimus
    0378-2046TacrolimusTacrolimus
    0378-2047TacrolimusTacrolimus

    Trademark Results [Envarsus]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ENVARSUS
    ENVARSUS
    79133181 4457206 Live/Registered
    Veloxis Pharmaceuticals A/S
    2013-02-07

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