FDA.reportPublic FDA data

VIJOICE

Product NDC
0078-1035
11-digit product format
000781035
Labeler code
0078
Product ID
0078-1035_6993f70f-a922-4520-9537-ec6cea3bd915
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alpelisib
Dosage form
KIT
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA215039
Marketing category
NDA
Marketing start
2022-04-05
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215039-001VIJOICEALPELISIB50MGTABLET / ORALRLD2022-04-05
N215039-002VIJOICEALPELISIB125MGTABLET / ORALRLD2022-04-05
N215039-003VIJOICEALPELISIB200MGTABLET / ORALRLD, RS2022-04-05

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215039-00184762682029-09-10Drug substance, Drug product2022-05-03
N215039-00182274622033-04-29Drug substance, Drug product2022-05-03
N215039-001114330592037-02-17U-43592025-12-22
N215039-001124271412037-02-17U-42882025-10-20
N215039-00284762682029-09-10Drug substance, Drug product2022-05-03
N215039-00282274622033-04-29Drug substance, Drug product2022-05-03
N215039-002114330592037-02-17U-43592025-12-22
N215039-002124271412037-02-17U-42882025-10-20
N215039-00384762682029-09-10Drug substance, Drug product2022-05-03
N215039-00382274622033-04-29Drug substance, Drug product2022-05-03
N215039-003114330592037-02-17U-43592025-12-22
N215039-003124271412037-02-17U-42882025-10-20

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N215039-001ODE-3962029-04-05
N215039-002ODE-3962029-04-05
N215039-003ODE-3962029-04-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N215039-001VIJOICE50MGTABLET / ORALRLD2022-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-002VIJOICE125MGTABLET / ORALRLD2022-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-003VIJOICE200MGTABLET / ORALRLD, RS2022-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-001VIJOICE50MGTABLET / ORALRLD2022-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-002VIJOICE125MGTABLET / ORALRLD2022-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-003VIJOICE200MGTABLET / ORALRLD, RS2022-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N215039-001VIJOICE50MGTABLET / ORALRLD2022-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215039-002VIJOICE125MGTABLET / ORALRLD2022-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215039-003VIJOICE200MGTABLET / ORALRLD, RS2022-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215039-001VIJOICE50MGTABLET / ORALRLD2022-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215039-002VIJOICE125MGTABLET / ORALRLD2022-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215039-003VIJOICE200MGTABLET / ORALRLD, RS2022-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215039-001VIJOICE50MGTABLET / ORALRLD2022-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215039-002VIJOICE125MGTABLET / ORALRLD2022-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215039-003VIJOICE200MGTABLET / ORALRLD, RS2022-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215039-001VIJOICE50MGTABLET / ORALRLD2022-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215039-002VIJOICE125MGTABLET / ORALRLD2022-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215039-003VIJOICE200MGTABLET / ORALRLD, RS2022-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215039-001VIJOICE50MGTABLET / ORALRLD2022-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215039-002VIJOICE125MGTABLET / ORALRLD2022-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215039-003VIJOICE200MGTABLET / ORALRLD, RS2022-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215039-001VIJOICE50MGTABLET / ORALRLD2022-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215039-002VIJOICE125MGTABLET / ORALRLD2022-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215039-003VIJOICE200MGTABLET / ORALRLD, RS2022-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215039-001VIJOICE50MGTABLET / ORALRLD2022-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215039-002VIJOICE125MGTABLET / ORALRLD2022-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215039-003VIJOICE200MGTABLET / ORALRLD, RS2022-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215039-001VIJOICE50MGTABLET / ORALRLD2022-04-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N215039-002VIJOICE125MGTABLET / ORALRLD2022-04-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N215039-003VIJOICE200MGTABLET / ORALRLD, RS2022-04-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215039-001VIJOICE50MGTABLET / ORALRLD2022-04-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215039-002VIJOICE125MGTABLET / ORALRLD2022-04-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215039-003VIJOICE200MGTABLET / ORALRLD, RS2022-04-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215039-001VIJOICE50MGTABLET / ORALRLD2022-04-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215039-002VIJOICE125MGTABLET / ORALRLD2022-04-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215039-003VIJOICE200MGTABLET / ORALRLD, RS2022-04-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215039-001VIJOICE50MGTABLET / ORALRLD2022-04-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215039-002VIJOICE125MGTABLET / ORALRLD2022-04-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215039-003VIJOICE200MGTABLET / ORALRLD, RS2022-04-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215039-001VIJOICE50MGTABLET / ORALRLD2022-04-058072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 5 · 189 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N215039-00184762682029-09-10Drug substance, Drug product2022-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-00182274622033-04-29Drug substance, Drug product2022-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-001114330592037-02-17U-43592025-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-001124271412037-02-17U-42882025-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-00284762682029-09-10Drug substance, Drug product2022-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-00282274622033-04-29Drug substance, Drug product2022-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-002114330592037-02-17U-43592025-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-002124271412037-02-17U-42882025-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-00384762682029-09-10Drug substance, Drug product2022-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-00382274622033-04-29Drug substance, Drug product2022-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-003114330592037-02-17U-43592025-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-003124271412037-02-17U-42882025-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-00184762682029-09-10Drug substance, Drug product2022-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-00182274622033-04-29Drug substance, Drug product2022-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-001124271412037-02-17U-42882025-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-00284762682029-09-10Drug substance, Drug product2022-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-00282274622033-04-29Drug substance, Drug product2022-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-002124271412037-02-17U-42882025-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-00384762682029-09-10Drug substance, Drug product2022-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-00382274622033-04-29Drug substance, Drug product2022-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-003124271412037-02-17U-42882025-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N215039-00184762682029-09-10Drug substance, Drug product2022-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215039-00182274622033-04-29Drug substance, Drug product2022-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215039-00284762682029-09-10Drug substance, Drug product2022-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215039-00282274622033-04-29Drug substance, Drug product2022-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215039-00384762682029-09-10Drug substance, Drug product2022-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215039-00382274622033-04-29Drug substance, Drug product2022-05-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215039-00184762682029-09-10Drug substance, Drug product2022-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215039-00182274622033-04-29Drug substance, Drug product2022-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215039-00284762682029-09-10Drug substance, Drug product2022-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215039-00282274622033-04-29Drug substance, Drug product2022-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215039-00384762682029-09-10Drug substance, Drug product2022-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215039-00382274622033-04-29Drug substance, Drug product2022-05-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215039-00184762682029-09-10Drug substance, Drug product2022-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215039-00182274622033-04-29Drug substance, Drug product2022-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215039-00284762682029-09-10Drug substance, Drug product2022-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215039-00282274622033-04-29Drug substance, Drug product2022-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215039-00384762682029-09-10Drug substance, Drug product2022-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215039-00382274622033-04-29Drug substance, Drug product2022-05-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215039-00184762682029-09-10Drug substance, Drug product2022-05-0303ed91905a0d…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 138 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N215039-001ODE-3962029-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-002ODE-3962029-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215039-003ODE-3962029-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-001ODE-3962029-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-002ODE-3962029-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215039-003ODE-3962029-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N215039-001ODE-3962029-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215039-002ODE-3962029-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215039-003ODE-3962029-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215039-001ODE-3962029-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215039-002ODE-3962029-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215039-003ODE-3962029-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215039-001ODE-3962029-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215039-002ODE-3962029-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215039-003ODE-3962029-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215039-001NCE2024-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215039-001ODE-3962029-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215039-002NCE2024-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215039-002ODE-3962029-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215039-003NCE2024-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215039-003ODE-3962029-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215039-001NCE2024-05-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215039-001ODE-3962029-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215039-002NCE2024-05-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215039-002ODE-3962029-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215039-003NCE2024-05-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215039-003ODE-3962029-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215039-001NCE2024-05-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215039-001ODE-3962029-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215039-002NCE2024-05-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215039-002ODE-3962029-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215039-003NCE2024-05-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215039-003ODE-3962029-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215039-001NCE2024-05-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215039-001ODE-3962029-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215039-002NCE2024-05-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215039-002ODE-3962029-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215039-003NCE2024-05-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215039-003ODE-3962029-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215039-001NCE2024-05-24d06236e962d9…

Additional Listing Data#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
08W5N2C97QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2169310Internal RxNorm lookup
2169316Internal RxNorm lookup
2169319Internal RxNorm lookup
2598459Internal RxNorm lookup
2598461Internal RxNorm lookup
2598463Internal RxNorm lookup
2598464Internal RxNorm lookup
2598465Internal RxNorm lookup
2598466Internal RxNorm lookup
2598467Internal RxNorm lookup
2598469Internal RxNorm lookup
2598470Internal RxNorm lookup
2680135Internal RxNorm lookup
2680138Internal RxNorm lookup
2680139Internal RxNorm lookup
2680140Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
638069a4-aee0-46c9-9e21-54ad449c163cAvailable on FDA.report

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, 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 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

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

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VIJOICEALPELISIBNovartis Pharmaceuticals Corporation638069a4-aee0-46c9-9e21-54ad449c163c2025-11-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 215039
application number: NDA215039
ndc (product): 0078-1035

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
0078-1035-02000781035022 BLISTER PACK in 1 CARTON (0078-1035-02) / 1 KIT in 1 BLISTER PACK (0078-1035-61) 2 blister pack2022-04-050000-00-00NoNoCurrent
0078-1035-61000781035611 in 1 BLISTER PACKHistorical
0078-1035-92000781035922 BLISTER PACK in 1 CARTON (0078-1035-92) / 1 KIT in 1 BLISTER PACK (0078-1035-94) 2 blister pack2022-04-050000-00-00YesNoCurrent
0078-1035-94000781035941 in 1 BLISTER PACKHistorical