FDA.reportPublic FDA data

NDC 63850-0061-01 - Everolimus

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63850-0061
Requested NDC
63850-0061-01
Package NDCs from labels
63850-0061-1, 63850-0061-4, 63850-0061-01
Manufacturer
Natco Pharma Limited | Natco Pharma Limited-Pharma Division
Effective date
2023-06-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Everolimus - Natco Pharma Limited | Natco Pharma Limited-Pharma DivisionNatco Pharma Limited | Natco Pharma Limited-Pharma Division2023-06-08Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63850-0061-1Everolimus4 in 1 CARTONTABLET47
63850-0061-1Everolimus7 in 1 BLISTER PACKTABLET77
63850-0061-4Everolimus30 in 1 BOTTLETABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63850-0061EVEROLIMUS TABLET [NATCO PHARMA LIMITED]7Current NDC, Legacy NDC, 3 package rows20230609_e3dbbc24-7e55-4069-a305-e2cded2db641.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PollutoxACETONE, ARSENICUM ALBUM, BENZINUM, BERBERIS VULGARIS, CADMIUM SULPHURATUM, CARBON DIOXIDE, CARBONEUM SULPHURATUM, CHLORINUM, HYDROFLUORICUM ACIDUM, MELATONIN, MERCURIUS SOLUBILIS, NITROGENUM OXYGENATUM, NUX VOMICA, OZONE, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, SULPHURICUM ACIDUM, TOLUENE, URANIUM NITRICUMDeseret Biologicals, Inc.741fdddf-75af-45a2-9875-ee3b08b0decf2026-09-08WarningsExact identifier
unii: 1364PS73AF
EverolimusEVEROLIMUSHikma Pharmaceuticals USA Inc.5aaf2fb7-93f6-40d6-941a-9583a3794ce72026-08-14Warnings, Adverse reactionsExact identifier
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
PollutoxSULPHURICUM ACIDUM, BERBERIS VULGARIS, ARSENICUM ALBUM, BENZINUM, CADMIUM SULPHURATUM, HYDROFLUORICUM ACIDUM, MELATONIN, NITROGENUM OXYGENATUM, NUX VOMICA, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, TOLUENE, ACETONE, CARBON DIOXIDE, CHLORINUM, MERCURIUS SOLUBILIS, OZONE, URANIUM NITRICUMDeseret Biologicals, Inc.e7000300-69ec-47db-8059-3f873d64f1772026-07-31WarningsExact identifier
unii: 1364PS73AF
EverolimusEVEROLIMUSi3 Pharmaceuticals, LLCbe5da0fd-8fd4-4f84-a307-f270048d503c2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EverolimusEVEROLIMUS TABLETSBreckenridge Pharmaceutical, Inc.c7bb6ba1-9a7f-43f5-b058-ef26d4b592212026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSBiocon Pharma Inc.5b809dfe-c076-07c5-207e-178c3f0d32d32026-06-30Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSTeva Pharmaceuticals USA, Inc.e3bca36b-29ed-4a2b-a1be-a57b6af805f62026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
EVEROLIMUSEVEROLIMUSAmneal Pharmaceuticals NY LLC6f1ae129-c21e-4c25-84c1-a6757d9a7eb22026-06-16Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
TORPENZEVEROLIMUSUpsher-Smith Laboratories, LLC4c0075dd-a0a8-4dc4-be32-1be8383fbbdc2026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
AfinitorEVEROLIMUSNovartis Pharmaceuticals Corporation2150f73a-179b-4afc-b8ce-67c85cc72f042026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
IndustrioxBERBERIS VULGARIS, TARAXACUM OFFICINALE, AMMONIUM CARBONICUM, CAMPHORA, SPINACIA, SULPHURICUM ACIDUM, NUX VOMICA, ACETONE, BENZINUM, BUTYL METHACRYLATE, CALCAREA CARBONICA, LACHESIS MUTUS, METHYL ETHYL KETONE, NAPHTHALINUM, PLUMBUM METALLICUM, TRICHLOROETHYLENE, FORLMALINUM, MTBE (TERT-BUTYL METHYL ETHER), PETROLEUM, CARBONEUM CHLORATUMNutritional Specialties, Inc.d77a58f8-68c3-4772-b938-473b203a1d472026-04-01WarningsExact identifier
unii: 1364PS73AF
YulithiraEVEROLIMUSCivicaScript, LLC5e325efa-8ae6-4dac-b59b-d7c74c73186c2026-03-31Warnings, Adverse reactionsExact identifier
application number: ANDA205426
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
everolimusEVEROLIMUSNovugen Pharma (USA) LLC.67e62e26-448d-46ec-b5a1-00dc1b5e26c62026-03-10Warnings, Adverse reactionsExact identifier
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
everolimusEVEROLIMUSAurobindo Pharma Limited43ef3c29-0e25-4fdd-aea1-06a20af9bbab2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
ZortressEVEROLIMUSNovartis Pharmaceuticals Corporatione082a024-7850-400b-a5c2-2a140612562a2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
Perfumox 6028PERFUMOXProfessional Complementary Health Formulasd27ac082-12fc-477d-a5c0-bb74f29c0e602026-01-08WarningsExact identifier
unii: 1364PS73AF
Industriox 6011INDUSTRIOXProfessional Complementary Health Formulasff4e04ce-6bff-419b-bb6b-d5e97b9942832026-01-08WarningsExact identifier
unii: 1364PS73AF
EverolimusEVEROLIMUSAscend Laboratories, LLC2693c497-a70b-4d00-b6db-602c872e5bed2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSNatco Pharma Limitedd44998bb-5deb-4ee7-a0a5-979fe3f495572025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSBreckenridge Pharmaceutical, Inc.01f7b5fb-be0d-4adf-acd2-6899018de9662025-09-05Warnings, Adverse reactionsExact identifier
application number: ANDA205426
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.