FDA.reportPublic FDA data

NDC 0078-0649-26 - Gleevec

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
0078-0649
Requested NDC
0078-0649-26
Package NDCs from labels
0078-0649-30, 0078-0649-26, 0078-0649-13
Manufacturer
Novartis Pharmaceuticals Corporation
Effective date
2026-07-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gleevec - Novartis Pharmaceuticals CorporationNovartis Pharmaceuticals Corporation2026-07-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0649-13Gleevec3 in 1 CARTONTABLET340
0078-0649-26Gleevec10 in 1 BLISTER PACKTABLET1040
0078-0649-30Gleevec30 in 1 BOX, UNIT-DOSETABLET3040

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0649GLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]35Current NDC, Legacy NDC, 3 package rows20240724_211ef2da-2868-4a77-8055-1cb2cd78e24b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0649-13EA - Each0078-064984666a8d-d71d-40ec-8842-436a304ef1b112024-10-04
0078-0649-26EA - Each0078-0649e9a4a6e7-d16e-4f9a-8156-9180cb0be6b912025-02-10
0078-0649-30EA - Each0078-06492a649688-be55-46c5-969f-422eeb366bdf12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IMATINIB MESYLATEACTIVE INGREDIENT8A1O1M485BGLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]16
IMATINIBACTIVE MOIETYBKJ8M8G5HIGLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]16
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]16
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]16
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]16
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]16
TALCINACTIVE INGREDIENT7SEV7J4R1UGLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]16

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 44 · 878 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
Imatinib MesylateIMATINIB MESYLATEApotex Corp0291eca5-7a1d-4a79-30be-252224d965092026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 403879
rxcui: 403878
unii: 8A1O1M485B
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Imatinib MesylateIMATINIB MESYLATEQUALLENT PHARMACEUTICALS HEALTH LLCa819a954-41c9-4d49-a74e-c8c4b338b22a2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 403879
rxcui: 403878
unii: 8A1O1M485B
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
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
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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

Reported adverse events (FAERS/openFDA)#

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