FDA.reportPublic FDA data

NDC 0078-0627-61 - Afinitor

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
0078-0627
Requested NDC
0078-0627-61
Package NDCs from labels
0078-0627-61, 0078-0627-51
Manufacturer
Novartis Pharmaceuticals Corporation
Effective date
2026-06-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Afinitor - Novartis Pharmaceuticals CorporationNovartis Pharmaceuticals Corporation2026-06-01HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-05-02Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-08-01These highlights do not include all the information needed to use AFINITOR/AFINITOR DISPERZ safely and effectively. See full prescribing information for AFINITOR/AFINITOR DISPERZ. AFINITOR ® (everolimus) tablets, for oral use AFINITOR DISPERZ ® (everolimus tablets for oral suspension) Initial U.S. Approval: 2009
2023-08-01These highlights do not include all the information needed to use AFINITOR/AFINITOR DISPERZ safely and effectively. See full prescribing information for AFINITOR/AFINITOR DISPERZ. AFINITOR ® (everolimus) tablets, for oral use AFINITOR DISPERZ ® (everolimus tablets for oral suspension) Initial U.S. Approval: 2009
2023-07-28These highlights do not include all the information needed to use AFINITOR/AFINITOR DISPERZ safely and effectively. See full prescribing information for AFINITOR/AFINITOR DISPERZ. AFINITOR ® (everolimus) tablets, for oral use AFINITOR DISPERZ ® (everolimus tablets for oral suspension) Initial U.S. Approval: 2009
2023-07-28These highlights do not include all the information needed to use AFINITOR/AFINITOR DISPERZ safely and effectively. See full prescribing information for AFINITOR/AFINITOR DISPERZ. AFINITOR ® (everolimus) tablets, for oral use AFINITOR DISPERZ ® (everolimus tablets for oral suspension) Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0627-51AfinitorDisperz28 in 1 CARTONTABLET, FOR SUSPENSION2866
0078-0627-61AfinitorDisperz1 in 1 BLISTER PACKTABLET, FOR SUSPENSION166

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0627AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]64Current NDC, Legacy NDC, 2 package rows20250515_2150f73a-179b-4afc-b8ce-67c85cc72f04.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0627-51EA - Each0078-0627df10573d-fa0f-43b6-983c-dadf78bbb8d712013-05-02
0078-0627-61EA - Each0078-0627e0a0a43f-380b-4f49-8896-b7630673f96212013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EVEROLIMUSACTIVE INGREDIENT9HW64Q8G6GAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
EVEROLIMUSACTIVE MOIETY9HW64Q8G6GAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
MANNITOLINACTIVE INGREDIENT3OWL53L36AAFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]34

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 34 · 671 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
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
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Drainage-ToneCALCAREA IODATA, CAPSICUM ANNUUM, COENZYME A, ECHINACEA ANGUSTIFOLIA, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, NADIDUM, NITRICUM ACIDUM, OLEUM MORRHUAE, PETROSELINUM SATIVUM, PHYTOLACCA DECANDRA, SCROPHULARIA NODOSA, SILICEA, SINAPIS ALBA, THUJA OCCIDENTALIS.Energetix Corporation296b455e-27c5-4f6e-929d-c4ee75b7fb0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmapathGELSEMIUM, GINKGO, GLYCYRRHIZA, HYDROCOTYLE, HYPOTHALAMUS, PETROSELINUM, PITUITARUM POSTERIUM, PYRIDOXINUM HYDROCHLORICUM, SENNA, SILICEAEnergetix Corporation3c4e2867-4d75-416b-9f3d-e6e500e46f6f2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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