NDC 0469-0657

Prograf

Tacrolimus

Prograf is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Astellas Pharma Us, Inc.. The primary component is Tacrolimus.

Product ID0469-0657_42ba828f-429f-4270-8758-e9d1ebb7855f
NDC0469-0657
Product TypeHuman Prescription Drug
Proprietary NamePrograf
Generic NameTacrolimus
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date1994-04-08
Marketing CategoryNDA / NDA
Application NumberNDA050708
Labeler NameAstellas Pharma US, Inc.
Substance NameTACROLIMUS
Active Ingredient Strength5 mg/1
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0469-0657-11

10 BLISTER PACK in 1 CARTON (0469-0657-11) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Marketing Start Date1994-04-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0469-0657-11 [00469065711]

Prograf CAPSULE, GELATIN COATED
Marketing CategoryNDA
Application NumberNDA050708
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1994-04-08

NDC 0469-0657-73 [00469065773]

Prograf CAPSULE, GELATIN COATED
Marketing CategoryNDA
Application NumberNDA050708
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1994-04-08

Drug Details

Active Ingredients

IngredientStrength
TACROLIMUS5 mg/1

OpenFDA Data

SPL SET ID:7f667de1-9dfa-4bd6-8ba0-15ee2d78873b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198378
  • 198379
  • 2052704
  • 198377
  • 261134
  • 313190
  • 2052609
  • 2052703
  • 2052605
  • 108515
  • 108514
  • 108513
  • UPC Code
  • 0304690607731
  • 0304693016011
  • 0304690657736
  • 0304690617730
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0469-0607PrografTacrolimus
    0469-0617PrografTacrolimus
    0469-0657PrografTacrolimus
    0469-1230PrografPrograf
    0469-1330PrografPrograf
    0469-3016PrografPrograf
    21695-170PrografPrograf
    43353-178PrografPrograf
    0093-3428Tacrolimustacrolimus
    0093-3429Tacrolimustacrolimus
    0168-0416Tacrolimustacrolimus
    0168-0417Tacrolimustacrolimus
    0378-2045TacrolimusTacrolimus
    0378-2046TacrolimusTacrolimus
    0378-2047TacrolimusTacrolimus

    Trademark Results [Prograf]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROGRAF
    PROGRAF
    74177939 1867420 Live/Registered
    ASTELLAS PHARMA INC.
    1991-06-20

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