NDC 65841-771

sirolimus

Sirolimus

sirolimus is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Sirolimus.

Product ID65841-771_00509d99-79dc-4ffd-94c9-8b172528de0a
NDC65841-771
Product TypeHuman Prescription Drug
Proprietary Namesirolimus
Generic NameSirolimus
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-01-15
Marketing CategoryANDA / ANDA
Application NumberANDA201676
Labeler NameZydus Lifesciences Limited
Substance NameSIROLIMUS
Active Ingredient Strength1 mg/1
Pharm ClassesDecreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65841-771-01

100 TABLET, FILM COATED in 1 BOTTLE (65841-771-01)
Marketing Start Date2014-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65841-771-16 [65841077116]

sirolimus TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201676
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-15
Marketing End Date2018-03-06

NDC 65841-771-05 [65841077105]

sirolimus TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201676
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-15
Marketing End Date2018-03-06

NDC 65841-771-10 [65841077110]

sirolimus TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201676
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-15
Marketing End Date2018-03-06

NDC 65841-771-01 [65841077101]

sirolimus TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201676
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-15

NDC 65841-771-77 [65841077177]

sirolimus TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201676
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-15
Marketing End Date2018-03-06

NDC 65841-771-06 [65841077106]

sirolimus TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201676
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-15
Marketing End Date2018-03-06

NDC 65841-771-30 [65841077130]

sirolimus TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201676
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-15
Marketing End Date2018-03-06

Drug Details

Active Ingredients

IngredientStrength
SIROLIMUS.5 mg/1

OpenFDA Data

SPL SET ID:82562b68-224d-482a-b399-a89b81d5eb31
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905158

    • 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 "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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