Home NDC 0078-1028 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215039-001 VIJOICE ALPELISIB 50MG TABLET / ORAL RLD 2022-04-05 N215039-002 VIJOICE ALPELISIB 125MG TABLET / ORAL RLD 2022-04-05 N215039-003 VIJOICE ALPELISIB 200MG TABLET / ORAL RLD, RS 2022-04-05
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215039-001 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 N215039-001 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 N215039-001 11433059 2037-02-17 U-4359 2025-12-22 N215039-001 12427141 2037-02-17 U-4288 2025-10-20 N215039-002 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 N215039-002 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 N215039-002 11433059 2037-02-17 U-4359 2025-12-22 N215039-002 12427141 2037-02-17 U-4288 2025-10-20 N215039-003 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 N215039-003 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 N215039-003 11433059 2037-02-17 U-4359 2025-12-22 N215039-003 12427141 2037-02-17 U-4288 2025-10-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215039-001 ODE-396 2029-04-05 N215039-002 ODE-396 2029-04-05 N215039-003 ODE-396 2029-04-05
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 · 90 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N215039-001 VIJOICE 50MG TABLET / ORAL RLD 2022-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215039-002 VIJOICE 125MG TABLET / ORAL RLD 2022-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215039-003 VIJOICE 200MG TABLET / ORAL RLD, RS 2022-04-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215039-001 VIJOICE 50MG TABLET / ORAL RLD 2022-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215039-002 VIJOICE 125MG TABLET / ORAL RLD 2022-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215039-003 VIJOICE 200MG TABLET / ORAL RLD, RS 2022-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215039-001 VIJOICE 50MG TABLET / ORAL RLD 2022-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215039-002 VIJOICE 125MG TABLET / ORAL RLD 2022-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215039-003 VIJOICE 200MG TABLET / ORAL RLD, RS 2022-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215039-001 VIJOICE 50MG TABLET / ORAL RLD 2022-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215039-002 VIJOICE 125MG TABLET / ORAL RLD 2022-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215039-003 VIJOICE 200MG TABLET / ORAL RLD, RS 2022-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215039-001 VIJOICE 50MG TABLET / ORAL RLD 2022-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215039-002 VIJOICE 125MG TABLET / ORAL RLD 2022-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215039-003 VIJOICE 200MG TABLET / ORAL RLD, RS 2022-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215039-001 VIJOICE 50MG TABLET / ORAL RLD 2022-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215039-002 VIJOICE 125MG TABLET / ORAL RLD 2022-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215039-003 VIJOICE 200MG TABLET / ORAL RLD, RS 2022-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215039-001 VIJOICE 50MG TABLET / ORAL RLD 2022-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215039-002 VIJOICE 125MG TABLET / ORAL RLD 2022-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215039-003 VIJOICE 200MG TABLET / ORAL RLD, RS 2022-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215039-001 VIJOICE 50MG TABLET / ORAL RLD 2022-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215039-002 VIJOICE 125MG TABLET / ORAL RLD 2022-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215039-003 VIJOICE 200MG TABLET / ORAL RLD, RS 2022-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215039-001 VIJOICE 50MG TABLET / ORAL RLD 2022-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215039-002 VIJOICE 125MG TABLET / ORAL RLD 2022-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215039-003 VIJOICE 200MG TABLET / ORAL RLD, RS 2022-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215039-001 VIJOICE 50MG TABLET / ORAL RLD 2022-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215039-002 VIJOICE 125MG TABLET / ORAL RLD 2022-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215039-003 VIJOICE 200MG TABLET / ORAL RLD, RS 2022-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215039-001 VIJOICE 50MG TABLET / ORAL RLD 2022-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215039-002 VIJOICE 125MG TABLET / ORAL RLD 2022-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215039-003 VIJOICE 200MG TABLET / ORAL RLD, RS 2022-04-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215039-001 VIJOICE 50MG TABLET / ORAL RLD 2022-04-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215039-002 VIJOICE 125MG TABLET / ORAL RLD 2022-04-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215039-003 VIJOICE 200MG TABLET / ORAL RLD, RS 2022-04-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215039-001 VIJOICE 50MG TABLET / ORAL RLD 2022-04-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215039-002 VIJOICE 125MG TABLET / ORAL RLD 2022-04-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215039-003 VIJOICE 200MG TABLET / ORAL RLD, RS 2022-04-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215039-001 VIJOICE 50MG TABLET / ORAL RLD 2022-04-05 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 6 · 201 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N215039-001 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215039-001 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215039-001 11433059 2037-02-17 U-4359 2025-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215039-001 12427141 2037-02-17 U-4288 2025-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215039-002 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215039-002 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215039-002 11433059 2037-02-17 U-4359 2025-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215039-002 12427141 2037-02-17 U-4288 2025-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215039-003 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215039-003 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215039-003 11433059 2037-02-17 U-4359 2025-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215039-003 12427141 2037-02-17 U-4288 2025-10-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215039-001 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215039-001 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215039-001 11433059 2037-02-17 U-4359 2025-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215039-001 12427141 2037-02-17 U-4288 2025-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215039-002 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215039-002 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215039-002 11433059 2037-02-17 U-4359 2025-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215039-002 12427141 2037-02-17 U-4288 2025-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215039-003 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215039-003 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215039-003 11433059 2037-02-17 U-4359 2025-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215039-003 12427141 2037-02-17 U-4288 2025-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215039-001 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215039-001 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215039-001 12427141 2037-02-17 U-4288 2025-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215039-002 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215039-002 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215039-002 12427141 2037-02-17 U-4288 2025-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215039-003 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215039-003 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215039-003 12427141 2037-02-17 U-4288 2025-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215039-001 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215039-001 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215039-002 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215039-002 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215039-003 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215039-003 8227462 2033-04-29 Drug substance, Drug product 2022-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215039-001 8476268 2029-09-10 Drug substance, Drug product 2022-05-03 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 141 observed states.
Additional Listing Data#
Finished product Yes
Brand name base VIJOICE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALPELISIB 125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 08W5N2C97Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 16 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0078-1028-84 2023-08-01 These 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 0078-1028-84 2023-08-01 These 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 0078-1028-91 2023-08-01 These 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 0078-1028-91 2023-08-01 These 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 0078-1028-84 2023-07-28 These 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 0078-1028-84 2023-07-28 These 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 0078-1028-91 2023-07-28 These 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 0078-1028-91 2023-07-28 These 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-1028 VIJOICE (ALPELISIB) TABLET VIJOICE (ALPELISIB) KIT VIJOICE (ALPELISIB) GRANULE [NOVARTIS PHARMACEUTICALS CORPORATION] 7 Current NDC, Legacy NDC, 4 package rows 20240724_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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VIJOICE ALPELISIB Novartis Pharmaceuticals Corporation 638069a4-aee0-46c9-9e21-54ad449c163c 2025-11-04 Warnings, Adverse reactions Exact identifier application applno (NDA): 215039 application number: NDA215039 ndc (product): 0078-1028
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-1028-51 00078102851 28 in 1 BLISTER PACK Historical 0078-1028-84 00078102884 1 BLISTER PACK in 1 CARTON (0078-1028-84) / 28 TABLET in 1 BLISTER PACK (0078-1028-51) 1 blister pack 2022-04-05 0000-00-00 No No Current 0078-1028-90 00078102890 28 in 1 BLISTER PACK Historical 0078-1028-91 00078102891 1 BLISTER PACK in 1 CARTON (0078-1028-91) / 28 TABLET in 1 BLISTER PACK (0078-1028-90) 1 blister pack 2022-04-05 0000-00-00 Yes No Current