VIJOICE

Product NDC: 0078-1175
11-digit product format: 000781175
Labeler code: 0078
Product ID: 0078-1175_6993f70f-a922-4520-9537-ec6cea3bd915
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alpelisib
Dosage form: GRANULE
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA218466
Marketing category: NDA
Marketing start: 2024-04-24
Substance: ALPELISIB
Active strength: 50 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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N218466-001	VIJOICE	ALPELISIB	50MG/PACKET	GRANULE / ORAL		RLD, RS	2024-04-24

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15
N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15
N218466-001	11433059	2037-02-17	U-4359		2025-12-22
N218466-001	12427141	2037-02-17	U-4288		2025-10-20

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N218466-001	VIJOICE	50MG/PACKET	GRANULES / ORAL	RLD, RS	2024-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218466-001	VIJOICE	50MG/PACKET	GRANULES / ORAL	RLD, RS	2024-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218466-001	VIJOICE	50MG/PACKET	GRANULES / ORAL	RLD, RS	2024-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218466-001	VIJOICE	50MG/PACKET	GRANULES / ORAL	RLD, RS	2024-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218466-001	VIJOICE	50MG/PACKET	GRANULES / ORAL	RLD, RS	2024-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218466-001	VIJOICE	50MG/PACKET	GRANULES / ORAL	RLD, RS	2024-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218466-001	VIJOICE	50MG/PACKET	GRANULES / ORAL	RLD, RS	2024-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218466-001	VIJOICE	50MG/PACKET	GRANULES / ORAL	RLD, RS	2024-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218466-001	VIJOICE	50MG/PACKET	GRANULES / ORAL	RLD, RS	2024-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218466-001	VIJOICE	50MG/PACKET	GRANULES / ORAL	RLD, RS	2024-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218466-001	VIJOICE	50MG/PACKET	GRANULES / ORAL	RLD, RS	2024-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218466-001	VIJOICE	50MG/PACKET	GRANULES / ORAL	RLD, RS	2024-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218466-001	VIJOICE	50MG/PACKET	GRANULES / ORAL	RLD, RS	2024-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218466-001	VIJOICE	50MG/PACKET	GRANULES / ORAL	RLD, RS	2024-04-24	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218466-001	VIJOICE	50MG/PACKET	GRANULE / ORAL	RLD, RS	2024-04-24	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218466-001	11433059	2037-02-17	U-4359		2025-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218466-001	12427141	2037-02-17	U-4288		2025-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218466-001	12427141	2037-02-17	U-4288		2025-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218466-001	8476268	2029-09-10		Drug substance, Drug product	2024-05-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218466-001	8227462	2033-04-29		Drug substance, Drug product	2024-05-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218466-001	11433059	2037-02-17	U-4359		2025-12-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218466-001	12427141	2037-02-17	U-4288		2025-10-20	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALPELISIB	50 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.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
638069a4-aee0-46c9-9e21-54ad449c163c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
85724d2f-3de1-4648-ab29-82124dc817cc	Product name	2	20250211
ffa47de3-b159-4b49-aed7-1387fbb5d311	Product name	1	20190828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0078-1175-19	VIJOICE	1 in 1 PACKET	GRANULE	1		10
0078-1175-51	VIJOICE	28 in 1 CARTON	GRANULE	28		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-1175-19	EA - Each	0078-1175	3f63c003-b06a-4bfd-812c-51491edd784c	1	2024-07-12
0078-1175-51	EA - Each	0078-1175	f992681f-eddd-4b06-a489-e04f3fa7fa25	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-1175	VIJOICE (ALPELISIB) TABLET VIJOICE (ALPELISIB) KIT VIJOICE (ALPELISIB) GRANULE [NOVARTIS PHARMACEUTICALS CORPORATION]	7	Current NDC, 2 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): 218466 application number: NDA218466 ndc (product): 0078-1175

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
08W5N2C97Q	ALPELISIB	1217486-61-7	ALPELISIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2598465	{28 (alpelisib 125 MG Oral Tablet [Vijoice]) } Pack [Vijoice 125 MG 28 Day]	BPCK	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598470	{28 (alpelisib 200 MG Oral Tablet [Vijoice]) / 28 (alpelisib 50 MG Oral Tablet [Vijoice]) } Pack [Vijoice 250 MG 28 Day]	BPCK	638069a4-aee0-46c9-9e21-54ad449c163c	10
2680140	{28 (alpelisib 50 MG Oral Granules [Vijoice]) } Pack [Vijoice 50 MG Granules 28 Day]	BPCK	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598467	{28 (alpelisib 50 MG Oral Tablet [Vijoice]) } Pack [Vijoice 50 MG 28 Day]	BPCK	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598464	{28 (alpelisib 125 MG Oral Tablet) } Pack	GPCK	638069a4-aee0-46c9-9e21-54ad449c163c	10
2169319	{28 (alpelisib 200 MG Oral Tablet) / 28 (alpelisib 50 MG Oral Tablet) } Pack	GPCK	638069a4-aee0-46c9-9e21-54ad449c163c	10
2680139	{28 (alpelisib 50 MG Oral Granules) } Pack	GPCK	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598466	{28 (alpelisib 50 MG Oral Tablet) } Pack	GPCK	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598461	alpelisib 125 MG Oral Tablet	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598464	alpelisib 125 MG Oral Tablet, 28 Day Pack	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2169319	alpelisib 200 MG (28) Oral Tablet / alpelisib 50 MG Oral Tablet (28) Oral Tablet, 250 MG Daily Dose Pack	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2169310	alpelisib 200 MG Oral Tablet	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598466	alpelisib 50 MG 28 Day Pack	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2680135	alpelisib 50 MG Oral Granules	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2680139	alpelisib 50 MG Oral Granules 28 Day Pack	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2169316	alpelisib 50 MG Oral Tablet	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598465	Vijoice 125 MG 28 Day Pack	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598463	Vijoice 125 MG Oral Tablet	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598469	Vijoice 200 MG Oral Tablet	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598470	Vijoice 250 MG 28 Day Pack	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598467	Vijoice 50 MG 28 Day Pack	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2680138	Vijoice 50 MG Oral Granules	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2680140	Vijoice 50 MG Oral Granules 28 Day Pack	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598459	Vijoice 50 MG Oral Tablet	PSN	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598463	alpelisib 125 MG Oral Tablet [Vijoice]	SBD	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598469	alpelisib 200 MG Oral Tablet [Vijoice]	SBD	638069a4-aee0-46c9-9e21-54ad449c163c	10
2680138	alpelisib 50 MG Oral Granules [Vijoice]	SBD	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598459	alpelisib 50 MG Oral Tablet [Vijoice]	SBD	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598461	alpelisib 125 MG Oral Tablet	SCD	638069a4-aee0-46c9-9e21-54ad449c163c	10
2169310	alpelisib 200 MG Oral Tablet	SCD	638069a4-aee0-46c9-9e21-54ad449c163c	10
2680135	alpelisib 50 MG Oral Granules	SCD	638069a4-aee0-46c9-9e21-54ad449c163c	10
2169316	alpelisib 50 MG Oral Tablet	SCD	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598464	alpelisib 125 MG (28) Oral Tablet, 28 Day Pack	SY	638069a4-aee0-46c9-9e21-54ad449c163c	10
2169319	alpelisib 200 MG (28) Oral Tablet / alpelisib 50 MG Oral Tablet (28) Oral Tablet, 250 MG Daily Dose Pack	SY	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598466	alpelisib 50 MG 28 Day Pack	SY	638069a4-aee0-46c9-9e21-54ad449c163c	10
2680135	alpelisib 50 MG Oral Granules	SY	638069a4-aee0-46c9-9e21-54ad449c163c	10
2680139	alpelisib 50 MG Oral Granules 28 Day Pack	SY	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598465	Vijoice 125 MG 28 Day Pack	SY	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598463	Vijoice 125 MG Oral Tablet	SY	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598469	Vijoice 200 MG Oral Tablet	SY	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598470	Vijoice 250 MG 28 Day Pack	SY	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598467	Vijoice 50 MG 28 Day Pack	SY	638069a4-aee0-46c9-9e21-54ad449c163c	10
2680138	Vijoice 50 MG Oral Granules	SY	638069a4-aee0-46c9-9e21-54ad449c163c	10
2680140	Vijoice 50 MG Oral Granules 28 Day Pack	SY	638069a4-aee0-46c9-9e21-54ad449c163c	10
2598459	Vijoice 50 MG Oral Tablet	SY	638069a4-aee0-46c9-9e21-54ad449c163c	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0078-1175-19	00078117519	1 in 1 PACKET					Historical
0078-1175-51	00078117551	28 PACKET in 1 CARTON (0078-1175-51) / 1 GRANULE in 1 PACKET (0078-1175-19)	28 packet	2024-04-24	No	No	Current