NDC 50268-718

Sirolimus

Sirolimus

Sirolimus is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Avpak. The primary component is Sirolimus.

Product ID50268-718_834ca58d-4cae-e42f-e053-2a91aa0a79c1
NDC50268-718
Product TypeHuman Prescription Drug
Proprietary NameSirolimus
Generic NameSirolimus
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-04-23
Marketing CategoryANDA / ANDA
Application NumberANDA201578
Labeler NameAvPAK
Substance NameSIROLIMUS
Active Ingredient Strength1 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 Through2020-12-31

Packaging

NDC 50268-718-13

30 BLISTER PACK in 1 BOX (50268-718-13) > 1 TABLET in 1 BLISTER PACK (50268-718-11)
Marketing Start Date2018-04-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50268-718-11 [50268071811]

Sirolimus TABLET
Marketing CategoryANDA
Application NumberANDA201578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-23

NDC 50268-718-13 [50268071813]

Sirolimus TABLET
Marketing CategoryANDA
Application NumberANDA201578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-23

Drug Details

Active Ingredients

IngredientStrength
SIROLIMUS1 mg/1

OpenFDA Data

SPL SET ID:6a85ad01-8144-4d9c-e053-2991aa0a4f85
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349208
  • Pharmacological Class

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

    Medicade Reported Pricing

    50268071813 SIROLIMUS 1 MG TABLET

    Pricing Unit: EA | Drug Type:

    50268071811 SIROLIMUS 1 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    0904-7147sirolimussirolimus
    0904-7248SirolimusSirolimus
    13668-658SirolimusSirolimus
    16714-187sirolimussirolimus
    16714-188sirolimussirolimus
    16714-189sirolimussirolimus
    68084-956SirolimusSirolimus
    68084-915SirolimusSirolimus
    68382-520sirolimussirolimus
    70954-075SirolimusSirolimus
    50268-718SirolimusSirolimus
    55111-654SirolimusSirolimus
    55111-653SirolimusSirolimus
    59762-1002SirolimusSirolimus
    59762-1003SirolimusSirolimus
    59762-1001SirolimusSirolimus
    65841-771sirolimussirolimus
    66689-347SirolimusSirolimus
    59762-1205SirolimusSirolimus
    69238-1594SirolimusSirolimus
    60505-6197SirolimusSirolimus
    68462-682sirolimussirolimus
    68462-684sirolimussirolimus
    68462-683sirolimussirolimus
    0008-1030RapamuneSIROLIMUS
    0008-1040RapamuneSIROLIMUS
    0008-1041RapamuneSIROLIMUS
    0008-1042RapamuneSIROLIMUS

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