NDC 42291-754

Tacrolimus

Tacrolimus Capsules

Tacrolimus is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Avkare. The primary component is Tacrolimus.

Product ID42291-754_a1366897-9f87-de1c-e053-2a95a90a64ab
NDC42291-754
Product TypeHuman Prescription Drug
Proprietary NameTacrolimus
Generic NameTacrolimus Capsules
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-03-19
Marketing CategoryANDA / ANDA
Application NumberANDA206651
Labeler NameAvKARE
Substance NameTACROLIMUS
Active Ingredient Strength5 mg/1
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 42291-754-01

100 CAPSULE in 1 BOTTLE (42291-754-01)
Marketing Start Date2020-03-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-754-01 [42291075401]

Tacrolimus CAPSULE
Marketing CategoryANDA
Application NumberANDA206651
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-19

Drug Details

Active Ingredients

IngredientStrength
TACROLIMUS5 mg/1

OpenFDA Data

SPL SET ID:a136688e-42a0-d318-e053-2995a90ac9d3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198378
  • 198377
  • 313190

    • Pharmacological Class

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

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

    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.