FDA.reportPublic FDA data

NDC 0093-7769-19 - 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
0093-7769
Requested NDC
0093-7769-19
Package NDCs from labels
0093-7769-19, 0093-7769-24
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2026-06-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Everolimus - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2026-06-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7769-19Everolimus1 in 1 BLISTER PACKTABLET110
0093-7769-24Everolimus28 in 1 CARTONTABLET2810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7769EVEROLIMUS TABLET [TEVA PHARMACEUTICALS USA, INC.]82 package rows20250216_e3bca36b-29ed-4a2b-a1be-a57b6af805f6.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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EverolimusEVEROLIMUSHikma Pharmaceuticals USA Inc.5aaf2fb7-93f6-40d6-941a-9583a3794ce72026-08-14Warnings, Adverse reactionsExact identifier
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
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
application number: ANDA210050
ndc (package): 0093-7767-24
ndc (package): 0093-7769-24
ndc (package): 0093-7769-19
ndc (package): 0093-7766-24
ndc (package): 0093-7767-19
ndc (package): 0093-7768-24
ndc (package): 0093-7768-19
ndc (package): 0093-7766-19
ndc (product): 0093-7768
ndc (product): 0093-7767
ndc (product): 0093-7769
ndc (product): 0093-7766
ndc11 (package): 00093776919
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
spl id: 0f7ea770-928b-43b2-8971-849d1d12bbc8
spl set id: e3bca36b-29ed-4a2b-a1be-a57b6af805f6
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
YulithiraEVEROLIMUSCivicaScript, LLC5e325efa-8ae6-4dac-b59b-d7c74c73186c2026-03-31Warnings, Adverse reactionsExact identifier
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
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
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSBiocon Pharma Inc.435da284-ef0e-ca90-e0db-bab9382922e02025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EVEROLIMUSEVEROLIMUSBiocon Pharma Inc.5fb55800-f322-6bb6-9dde-622925ef28bd2025-03-21Warnings, Adverse reactionsExact identifier
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSPar Health USA, LLC59cb86d5-8706-4619-b074-af253d3e0b682025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSHikma Pharmaceuticals USA Inc.cf2dd54b-7a1d-4401-9a01-75e68235e4332024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
Multi-PhenolicMANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,Energique, Inc.492b412a-01cc-48f2-bcdc-6fffcc6519632024-08-23WarningsExact identifier
unii: 1P9D0Z171K

Reported adverse events (FAERS/openFDA)#

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