NDC 0168-0417

Tacrolimus

Tacrolimus

Tacrolimus is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Tacrolimus.

Product ID0168-0417_48c43415-57e7-4aca-9e66-cc05562a3f10
NDC0168-0417
Product TypeHuman Prescription Drug
Proprietary NameTacrolimus
Generic NameTacrolimus
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2014-09-09
Marketing CategoryANDA / ANDA
Application NumberANDA200744
Labeler NameE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Substance NameTACROLIMUS
Active Ingredient Strength0 mg/g
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0168-0417-30

1 TUBE in 1 CARTON (0168-0417-30) > 30 g in 1 TUBE
Marketing Start Date2014-09-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0417-30 [00168041730]

Tacrolimus OINTMENT
Marketing CategoryANDA
Application NumberANDA200744
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2014-09-09

NDC 0168-0417-99 [00168041799]

Tacrolimus OINTMENT
Marketing CategoryANDA
Application NumberANDA200744
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2014-09-09

NDC 0168-0417-60 [00168041760]

Tacrolimus OINTMENT
Marketing CategoryANDA
Application NumberANDA200744
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2014-09-09

Drug Details

Active Ingredients

IngredientStrength
TACROLIMUS.3 mg/g

OpenFDA Data

SPL SET ID:1bf44a84-14fd-4f80-ad8a-99b1431d631f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314266
  • 313189
  • UPC Code
  • 0301680416601
  • 0301680417608
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0093-3428Tacrolimustacrolimus
    0093-3429Tacrolimustacrolimus
    0168-0416Tacrolimustacrolimus
    0168-0417Tacrolimustacrolimus
    0378-2045TacrolimusTacrolimus
    0378-2046TacrolimusTacrolimus
    0378-2047TacrolimusTacrolimus
    68084-450TacrolimusTacrolimus
    68084-449TacrolimusTacrolimus
    68084-451TacrolimusTacrolimus
    68462-534TacrolimusTacrolimus
    69452-154TacrolimusTacrolimus
    69452-155TacrolimusTacrolimus
    69452-153TacrolimusTacrolimus
    70518-1168TacrolimusTacrolimus
    0781-2104TacrolimusTacrolimus
    0781-2102TacrolimusTacrolimus
    0781-2103TacrolimusTacrolimus
    0781-9302TacrolimusTacrolimus
    0781-9304TacrolimusTacrolimus
    0781-9303TacrolimusTacrolimus
    0904-6425TacrolimusTacrolimus
    0904-6624TacrolimusTacrolimus
    0904-6623TacrolimusTacrolimus
    16729-041TacrolimusTacrolimus
    16729-043TacrolimusTacrolimus
    16729-042TacrolimusTacrolimus
    43353-317TacrolimusTacrolimus
    43817-423TacrolimusTacrolimus
    43817-422TacrolimusTacrolimus
    43817-421TacrolimusTacrolimus
    45802-390TacrolimusTacrolimus
    45802-700TacrolimusTacrolimus
    50090-2245TacrolimusTacrolimus
    51079-817TacrolimusTacrolimus
    51079-818TacrolimusTacrolimus
    51079-028TacrolimusTacrolimus
    55111-525TacrolimusTacrolimus
    55111-526TacrolimusTacrolimus
    55111-527TacrolimusTacrolimus
    55154-5438TacrolimusTacrolimus
    55154-4395TacrolimusTacrolimus
    55154-2675TacrolimusTacrolimus
    60429-378TacrolimusTacrolimus
    60429-377TacrolimusTacrolimus
    60429-379TacrolimusTacrolimus
    62175-381TacrolimusTacrolimus
    62250-665TacrolimusTacrolimus
    62175-380TacrolimusTacrolimus
    62175-382TacrolimusTacrolimus

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