FDA.reportPublic FDA data

VIJOICE

Product NDC
0078-1028
11-digit product format
000781028
Labeler code
0078
Product ID
0078-1028_6993f70f-a922-4520-9537-ec6cea3bd915
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alpelisib
Dosage form
TABLET
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA215039
Marketing category
NDA
Marketing start
2022-04-05
Substance
ALPELISIB
Active strength
125 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VIJOICE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPELISIB125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii08W5N2C97Q
Rxcui2169310, 2169316, 2169319, 2598459, 2598461, 2598463, 2598464, 2598465, 2598466, 2598467, 2598469, 2598470, 2680135, 2680138, 2680139, 2680140

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
85724d2f-3de1-4648-ab29-82124dc817ccProduct name220250211
ffa47de3-b159-4b49-aed7-1387fbb5d311Product name120190828

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0078-1028-842023-08-01C16284748780-10191ceaa-6109-198a-e063-dbdaa90aec3eThese 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
0078-1028-842023-08-01C16284748780-10191ceaa-6109-198a-e063-dbdaa90aec3eThese 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
0078-1028-912023-08-01C16284748780-10191ceaa-6109-198a-e063-dbdaa90aec3eThese 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
0078-1028-912023-08-01C16284748780-10191ceaa-6109-198a-e063-dbdaa90aec3eThese 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
0078-1028-842023-07-28C16284748780-10191ceaa-6109-198a-e063-dbdaa90aec3eThese 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
0078-1028-842023-07-28C16284748780-10191ceaa-6109-198a-e063-dbdaa90aec3eThese 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
0078-1028-912023-07-28C16284748780-10191ceaa-6109-198a-e063-dbdaa90aec3eThese 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
0078-1028-912023-07-28C16284748780-10191ceaa-6109-198a-e063-dbdaa90aec3eThese 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
0078-1028-51VIJOICE28 in 1 BLISTER PACKTABLET2810
0078-1028-84VIJOICE1 in 1 CARTONTABLET110
0078-1028-90VIJOICE28 in 1 BLISTER PACKTABLET2810
0078-1028-91VIJOICE1 in 1 CARTONTABLET110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-1028-51EA - Each0078-10284a6ff28f-6edb-4ec1-b62b-daf49208b83212022-06-06
0078-1028-84EA - Each0078-10286f17099c-6d7c-4914-88f2-506c41dea8c812022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-1028VIJOICE (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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2598465{28 (alpelisib 125 MG Oral Tablet [Vijoice]) } Pack [Vijoice 125 MG 28 Day]BPCK638069a4-aee0-46c9-9e21-54ad449c163c10
2598470{28 (alpelisib 200 MG Oral Tablet [Vijoice]) / 28 (alpelisib 50 MG Oral Tablet [Vijoice]) } Pack [Vijoice 250 MG 28 Day]BPCK638069a4-aee0-46c9-9e21-54ad449c163c10
2680140{28 (alpelisib 50 MG Oral Granules [Vijoice]) } Pack [Vijoice 50 MG Granules 28 Day]BPCK638069a4-aee0-46c9-9e21-54ad449c163c10
2598467{28 (alpelisib 50 MG Oral Tablet [Vijoice]) } Pack [Vijoice 50 MG 28 Day]BPCK638069a4-aee0-46c9-9e21-54ad449c163c10
2598464{28 (alpelisib 125 MG Oral Tablet) } PackGPCK638069a4-aee0-46c9-9e21-54ad449c163c10
2169319{28 (alpelisib 200 MG Oral Tablet) / 28 (alpelisib 50 MG Oral Tablet) } PackGPCK638069a4-aee0-46c9-9e21-54ad449c163c10
2680139{28 (alpelisib 50 MG Oral Granules) } PackGPCK638069a4-aee0-46c9-9e21-54ad449c163c10
2598466{28 (alpelisib 50 MG Oral Tablet) } PackGPCK638069a4-aee0-46c9-9e21-54ad449c163c10
2598461alpelisib 125 MG Oral TabletPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2598464alpelisib 125 MG Oral Tablet, 28 Day PackPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2169319alpelisib 200 MG (28) Oral Tablet / alpelisib 50 MG Oral Tablet (28) Oral Tablet, 250 MG Daily Dose PackPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2169310alpelisib 200 MG Oral TabletPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2598466alpelisib 50 MG 28 Day PackPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2680135alpelisib 50 MG Oral GranulesPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2680139alpelisib 50 MG Oral Granules 28 Day PackPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2169316alpelisib 50 MG Oral TabletPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2598465Vijoice 125 MG 28 Day PackPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2598463Vijoice 125 MG Oral TabletPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2598469Vijoice 200 MG Oral TabletPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2598470Vijoice 250 MG 28 Day PackPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2598467Vijoice 50 MG 28 Day PackPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2680138Vijoice 50 MG Oral GranulesPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2680140Vijoice 50 MG Oral Granules 28 Day PackPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2598459Vijoice 50 MG Oral TabletPSN638069a4-aee0-46c9-9e21-54ad449c163c10
2598463alpelisib 125 MG Oral Tablet [Vijoice]SBD638069a4-aee0-46c9-9e21-54ad449c163c10
2598469alpelisib 200 MG Oral Tablet [Vijoice]SBD638069a4-aee0-46c9-9e21-54ad449c163c10
2680138alpelisib 50 MG Oral Granules [Vijoice]SBD638069a4-aee0-46c9-9e21-54ad449c163c10
2598459alpelisib 50 MG Oral Tablet [Vijoice]SBD638069a4-aee0-46c9-9e21-54ad449c163c10
2598461alpelisib 125 MG Oral TabletSCD638069a4-aee0-46c9-9e21-54ad449c163c10
2169310alpelisib 200 MG Oral TabletSCD638069a4-aee0-46c9-9e21-54ad449c163c10
2680135alpelisib 50 MG Oral GranulesSCD638069a4-aee0-46c9-9e21-54ad449c163c10
2169316alpelisib 50 MG Oral TabletSCD638069a4-aee0-46c9-9e21-54ad449c163c10
2598464alpelisib 125 MG (28) Oral Tablet, 28 Day PackSY638069a4-aee0-46c9-9e21-54ad449c163c10
2169319alpelisib 200 MG (28) Oral Tablet / alpelisib 50 MG Oral Tablet (28) Oral Tablet, 250 MG Daily Dose PackSY638069a4-aee0-46c9-9e21-54ad449c163c10
2598466alpelisib 50 MG 28 Day PackSY638069a4-aee0-46c9-9e21-54ad449c163c10
2680135alpelisib 50 MG Oral GranulesSY638069a4-aee0-46c9-9e21-54ad449c163c10
2680139alpelisib 50 MG Oral Granules 28 Day PackSY638069a4-aee0-46c9-9e21-54ad449c163c10
2598465Vijoice 125 MG 28 Day PackSY638069a4-aee0-46c9-9e21-54ad449c163c10
2598463Vijoice 125 MG Oral TabletSY638069a4-aee0-46c9-9e21-54ad449c163c10
2598469Vijoice 200 MG Oral TabletSY638069a4-aee0-46c9-9e21-54ad449c163c10
2598470Vijoice 250 MG 28 Day PackSY638069a4-aee0-46c9-9e21-54ad449c163c10
2598467Vijoice 50 MG 28 Day PackSY638069a4-aee0-46c9-9e21-54ad449c163c10
2680138Vijoice 50 MG Oral GranulesSY638069a4-aee0-46c9-9e21-54ad449c163c10
2680140Vijoice 50 MG Oral Granules 28 Day PackSY638069a4-aee0-46c9-9e21-54ad449c163c10
2598459Vijoice 50 MG Oral TabletSY638069a4-aee0-46c9-9e21-54ad449c163c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-1028-510007810285128 in 1 BLISTER PACKHistorical
0078-1028-84000781028841 BLISTER PACK in 1 CARTON (0078-1028-84) / 28 TABLET in 1 BLISTER PACK (0078-1028-51) 1 blister pack2022-04-050000-00-00NoNoCurrent
0078-1028-900007810289028 in 1 BLISTER PACKHistorical
0078-1028-91000781028911 BLISTER PACK in 1 CARTON (0078-1028-91) / 28 TABLET in 1 BLISTER PACK (0078-1028-90) 1 blister pack2022-04-050000-00-00YesNoCurrent