FDA.reportPublic FDA data

NDC 0078-0422-61 - Zortress

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
0078-0422
Requested NDC
0078-0422-61
Package NDCs from labels
0078-0422-61, 0078-0422-20
Manufacturer
Novartis Pharmaceuticals Corporation
Effective date
2026-09-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zortress - Novartis Pharmaceuticals CorporationNovartis Pharmaceuticals Corporation2026-09-16HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-08-01These highlights do not include all the information needed to use ZORTRESS safely and effectively. See full prescribing information for ZORTRESS. ZORTRESS ® (everolimus) tablets, for oral use Initial U.S. Approval: 2010
2023-08-01These highlights do not include all the information needed to use ZORTRESS safely and effectively. See full prescribing information for ZORTRESS. ZORTRESS ® (everolimus) tablets, for oral use Initial U.S. Approval: 2010
2023-07-28These highlights do not include all the information needed to use ZORTRESS safely and effectively. See full prescribing information for ZORTRESS. ZORTRESS ® (everolimus) tablets, for oral use Initial U.S. Approval: 2010
2023-07-28These highlights do not include all the information needed to use ZORTRESS safely and effectively. See full prescribing information for ZORTRESS. ZORTRESS ® (everolimus) tablets, for oral use Initial U.S. Approval: 2010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0422-20Zortress60 in 1 BOXTABLET6029
0078-0422-61Zortress1 in 1 BLISTER PACKTABLET129

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0422ZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]27Current NDC, Legacy NDC, 2 package rows20250105_e082a024-7850-400b-a5c2-2a140612562a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0422-20EA - Each0078-04220b14653c-96ac-4c80-9b72-5f58bae0948b12018-11-06
0078-0422-61EA - Each0078-042298ebd157-68eb-470b-91d5-74b5f3c212ac12018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EVEROLIMUSACTIVE INGREDIENT9HW64Q8G6GZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13
EVEROLIMUSACTIVE MOIETY9HW64Q8G6GZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13
CROSPOVIDONEINACTIVE INGREDIENT68401960MKZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]13

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 · 60 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
EverolimusEVEROLIMUSHikma Pharmaceuticals USA Inc.5aaf2fb7-93f6-40d6-941a-9583a3794ce72026-08-14Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
EverolimusEVEROLIMUSi3 Pharmaceuticals, LLCbe5da0fd-8fd4-4f84-a307-f270048d503c2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2056895
rxcui: 977427
rxcui: 977434
rxcui: 977438
unii: 9HW64Q8G6G
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
EverolimusEVEROLIMUS TABLETSBreckenridge Pharmaceutical, Inc.c7bb6ba1-9a7f-43f5-b058-ef26d4b592212026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2056895
rxcui: 977427
rxcui: 977434
rxcui: 977438
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
unii: 9HW64Q8G6G
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
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
unii: 9HW64Q8G6G
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
AfinitorEVEROLIMUSNovartis Pharmaceuticals Corporation2150f73a-179b-4afc-b8ce-67c85cc72f042026-06-01Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO
YulithiraEVEROLIMUSCivicaScript, LLC5e325efa-8ae6-4dac-b59b-d7c74c73186c2026-03-31Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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