NDC 0008-1042

Rapamune

Sirolimus

Rapamune is a Oral Tablet, Sugar Coated in the Human Prescription Drug category. It is labeled and distributed by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The primary component is Sirolimus.

Product ID0008-1042_2d77cb2a-e58f-4f95-a64c-d1efcc815f4a
NDC0008-1042
Product TypeHuman Prescription Drug
Proprietary NameRapamune
Generic NameSirolimus
Dosage FormTablet, Sugar Coated
Route of AdministrationORAL
Marketing Start Date2001-07-01
Marketing CategoryNDA / NDA
Application NumberNDA021110
Labeler NameWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Substance NameSIROLIMUS
Active Ingredient Strength2 mg/1
Pharm ClassesDecreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0008-1042-05

100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1042-05)
Marketing Start Date2001-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0008-1042-05 [00008104205]

Rapamune TABLET, SUGAR COATED
Marketing CategoryNDA
Application NumberNDA021110
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-07-01

Drug Details

Active Ingredients

IngredientStrength
SIROLIMUS2 mg/1

OpenFDA Data

SPL SET ID:3275b824-3f82-4151-2ab2-0036a9ba0acc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351989
  • 314230
  • 349208
  • 404432
  • 351901
  • 905160
  • 905158
  • 360110
  • UPC Code
  • 0300081041054
  • 0300081041108
  • 0300081040057
  • 0300081042051
  • 0300081040101
  • Pharmacological Class

    • Decreased Immunologic Activity [PE]
    • mTOR Inhibitor Immunosuppressant [EPC]
    • mTOR Inhibitors [MoA]
    • Kinase Inhibitor [EPC]
    • Protein Kinase Inhibitors [MoA]

    NDC Crossover Matching brand name "Rapamune" or generic name "Sirolimus"

    NDCBrand NameGeneric Name
    0008-1030RapamuneSIROLIMUS
    0008-1040RapamuneSIROLIMUS
    0008-1041RapamuneSIROLIMUS
    0008-1042RapamuneSIROLIMUS
    0904-7147sirolimussirolimus
    0904-7248SirolimusSirolimus
    13668-658SirolimusSirolimus
    16714-187sirolimussirolimus
    16714-188sirolimussirolimus
    16714-189sirolimussirolimus

    Trademark Results [Rapamune]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RAPAMUNE
    RAPAMUNE
    75618022 2425667 Live/Registered
    WYETH LLC
    1999-01-11
    RAPAMUNE
    RAPAMUNE
    74425732 1909128 Live/Registered
    WYETH LLC
    1993-08-18

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