FDA.reportPublic FDA data

NDC 0078-1035-94 - VIJOICE

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
0078-1035
Requested NDC
0078-1035-94
Package NDCs from labels
0078-1035-61, 0078-1035-02, 0078-1035-94, 0078-1035-92
Manufacturer
Novartis Pharmaceuticals Corporation
Effective date
2025-11-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VIJOICE - Novartis Pharmaceuticals CorporationNovartis Pharmaceuticals Corporation2025-11-04HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0078-1035-022023-08-01These highlights do not include all the information needed to use VIJOICE safely and effectively. See full prescribing information for VIJOICE. VIJOICE ® (alpelisib) tablets, for oral use VIJOICE ® (alpelisib) oral granules Initial U.S. Approval: 2019
0078-1035-022023-08-01These highlights do not include all the information needed to use VIJOICE safely and effectively. See full prescribing information for VIJOICE. VIJOICE ® (alpelisib) tablets, for oral use VIJOICE ® (alpelisib) oral granules Initial U.S. Approval: 2019
0078-1035-922023-08-01These highlights do not include all the information needed to use VIJOICE safely and effectively. See full prescribing information for VIJOICE. VIJOICE ® (alpelisib) tablets, for oral use VIJOICE ® (alpelisib) oral granules Initial U.S. Approval: 2019
0078-1035-922023-08-01These highlights do not include all the information needed to use VIJOICE safely and effectively. See full prescribing information for VIJOICE. VIJOICE ® (alpelisib) tablets, for oral use VIJOICE ® (alpelisib) oral granules Initial U.S. Approval: 2019
0078-1035-022023-07-28These highlights do not include all the information needed to use VIJOICE safely and effectively. See full prescribing information for VIJOICE. VIJOICE ® (alpelisib) tablets, for oral use VIJOICE ® (alpelisib) oral granules Initial U.S. Approval: 2019
0078-1035-022023-07-28These highlights do not include all the information needed to use VIJOICE safely and effectively. See full prescribing information for VIJOICE. VIJOICE ® (alpelisib) tablets, for oral use VIJOICE ® (alpelisib) oral granules Initial U.S. Approval: 2019
0078-1035-922023-07-28These highlights do not include all the information needed to use VIJOICE safely and effectively. See full prescribing information for VIJOICE. VIJOICE ® (alpelisib) tablets, for oral use VIJOICE ® (alpelisib) oral granules Initial U.S. Approval: 2019
0078-1035-922023-07-28These highlights do not include all the information needed to use VIJOICE safely and effectively. See full prescribing information for VIJOICE. VIJOICE ® (alpelisib) tablets, for oral use VIJOICE ® (alpelisib) oral granules Initial U.S. Approval: 2019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-1035-02VIJOICE2 in 1 CARTONKIT210
0078-1035-61VIJOICE1 in 1 BLISTER PACKKIT110
0078-1035-92VIJOICE2 in 1 CARTONKIT210
0078-1035-94VIJOICE1 in 1 BLISTER PACKKIT110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-1035VIJOICE (ALPELISIB) TABLET VIJOICE (ALPELISIB) KIT VIJOICE (ALPELISIB) GRANULE [NOVARTIS PHARMACEUTICALS CORPORATION]7Current NDC, Legacy NDC, 4 package rows20240724_638069a4-aee0-46c9-9e21-54ad449c163c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-1035-02EA - Each0078-10359a5ea18a-264c-4c24-8582-db19611b401512022-05-04
0078-1035-61EA - Each0078-1035aba84536-50fe-4f8c-8185-e816236faf0612022-06-06

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 106 · 2,112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
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
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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