PIQRAY

Product NDC: 0078-0715
11-digit product format: 000780715
Labeler code: 0078
Product ID: 0078-0715_b4a9e0a0-a882-485b-918f-7134992246ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alpelisib
Dosage form: KIT
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA212526
Marketing category: NDA
Marketing start: 2019-05-24
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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N212526-001	PIQRAY	ALPELISIB	50MG	TABLET / ORAL	RLD	2019-05-24
N212526-002	PIQRAY	ALPELISIB	150MG	TABLET / ORAL	RLD	2019-05-24
N212526-003	PIQRAY	ALPELISIB	200MG	TABLET / ORAL	RLD, RS	2019-05-24

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17
N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17
N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17
N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17
N212526-003	8476268	2029-09-10		Drug substance, Drug product	2019-06-17
N212526-003	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212526-001	I-937	2027-01-18
N212526-002	I-937	2027-01-18
N212526-003	I-937	2027-01-18

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 4 · 123 observed 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	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 observed states.

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	N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-003	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-003	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-003	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-003	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-003	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-003	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-003	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-003	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-003	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-003	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-003	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-003	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 150 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212526-001	I-937	2027-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-002	I-937	2027-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-003	I-937	2027-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-001	I-937	2027-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-002	I-937	2027-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-003	I-937	2027-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212526-001	I-937	2027-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-002	I-937	2027-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-003	I-937	2027-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-001	I-937	2027-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-002	I-937	2027-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-003	I-937	2027-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-001	I-937	2027-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-002	I-937	2027-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-003	I-937	2027-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-001	NCE	2024-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-001	I-937	2027-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-002	NCE	2024-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-002	I-937	2027-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-003	NCE	2024-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-003	I-937	2027-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-001	NCE	2024-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-001	I-937	2027-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-002	NCE	2024-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-002	I-937	2027-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-003	NCE	2024-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-003	I-937	2027-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-001	NCE	2024-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-001	I-937	2027-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-002	NCE	2024-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-002	I-937	2027-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-003	NCE	2024-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-003	I-937	2027-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-001	NCE	2024-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-001	I-937	2027-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-002	NCE	2024-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-002	I-937	2027-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-003	NCE	2024-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-003	I-937	2027-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212526-001	NCE	2024-05-24	`d06236e962d9…`

Additional Listing Data#

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

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 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2169300	Internal RxNorm lookup
2169307	Internal RxNorm lookup
2169310	Internal RxNorm lookup
2169311	Internal RxNorm lookup
2169313	Internal RxNorm lookup
2169314	Internal RxNorm lookup
2169316	Internal RxNorm lookup
2169318	Internal RxNorm lookup
2169319	Internal RxNorm lookup
2169320	Internal RxNorm lookup
2169321	Internal RxNorm lookup
2169322	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
b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0078-0715-02	2023-08-01	These highlights do not include all the information needed to use PIQRAY safely and effectively. See full prescribing information for PIQRAY. PIQRAY ® (alpelisib) tablets, for oral use Initial U.S. Approval: 2019
0078-0715-91	2023-08-01	These highlights do not include all the information needed to use PIQRAY safely and effectively. See full prescribing information for PIQRAY. PIQRAY ® (alpelisib) tablets, for oral use Initial U.S. Approval: 2019
0078-0715-02	2023-07-28	These highlights do not include all the information needed to use PIQRAY safely and effectively. See full prescribing information for PIQRAY. PIQRAY ® (alpelisib) tablets, for oral use Initial U.S. Approval: 2019
0078-0715-91	2023-07-28	These highlights do not include all the information needed to use PIQRAY safely and effectively. See full prescribing information for PIQRAY. PIQRAY ® (alpelisib) tablets, for oral use Initial U.S. Approval: 2019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0078-0715-02	PIQRAY	2 in 1 CARTON	KIT	2	13
0078-0715-61	PIQRAY	1 in 1 KIT	KIT	1	13
0078-0715-91	PIQRAY	1 in 1 CARTON	KIT	1	13
0078-0715-94	PIQRAY	1 in 1 KIT	KIT	1	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0715-02	EA - Each	0078-0715	c5b7efef-0ca0-4dba-9521-ae4c4dd078ac	1	2019-06-19
0078-0715-61	EA - Each	0078-0715	352f109c-026a-4927-830b-f3c6e15d6832	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0715	PIQRAY (ALPELISIB) TABLET PIQRAY (ALPELISIB) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]	12	Current NDC, Legacy NDC, 4 package rows	20250223_b20b4e18-7a4b-4500-a08f-06c6dab0ee5b.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
PIQRAY	ALPELISIB	Novartis Pharmaceuticals Corporation	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212526 application number: NDA212526 ndc (product): 0078-0715

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
2169314	{28 (alpelisib 200 MG Oral Tablet [Piqray]) } Pack [Piqray 200 MG Daily Dose]	BPCK	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169320	{28 (alpelisib 200 MG Oral Tablet [Piqray]) / 28 (alpelisib 50 MG Oral Tablet [Piqray]) } Pack [Piqray 250 MG Daily Dose]	BPCK	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169322	{56 (alpelisib 150 MG Oral Tablet [Piqray]) } Pack [Piqray 300 MG Daily Dose]	BPCK	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169311	{28 (alpelisib 200 MG Oral Tablet) } Pack	GPCK	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169319	{28 (alpelisib 200 MG Oral Tablet) / 28 (alpelisib 50 MG Oral Tablet) } Pack	GPCK	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169321	{56 (alpelisib 150 MG Oral Tablet) } Pack	GPCK	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169321	alpelisib 150 MG (56) Oral Tablet, 300 MG Daily Dose Pack	PSN	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169300	alpelisib 150 MG Oral Tablet	PSN	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169319	alpelisib 200 MG (28) Oral Tablet / alpelisib 50 MG Oral Tablet (28) Oral Tablet, 250 MG Daily Dose Pack	PSN	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169311	alpelisib 200 MG (28) Oral Tablet, 200 MG Daily Dose Pack	PSN	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169310	alpelisib 200 MG Oral Tablet	PSN	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169316	alpelisib 50 MG Oral Tablet	PSN	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169307	PIQRAY 150 MG Oral Tablet	PSN	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169314	PIQRAY 200 MG Daily Dose Pack	PSN	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169313	PIQRAY 200 MG Oral Tablet	PSN	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169320	PIQRAY 250 MG Daily Dose Pack	PSN	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169322	PIQRAY 300 MG Daily Dose Pack	PSN	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169318	PIQRAY 50 MG Oral Tablet	PSN	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169307	alpelisib 150 MG Oral Tablet [Piqray]	SBD	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169313	alpelisib 200 MG Oral Tablet [Piqray]	SBD	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169318	alpelisib 50 MG Oral Tablet [Piqray]	SBD	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169300	alpelisib 150 MG Oral Tablet	SCD	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169310	alpelisib 200 MG Oral Tablet	SCD	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169316	alpelisib 50 MG Oral Tablet	SCD	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169321	alpelisib 150 MG (56) Oral Tablet, 300 MG Daily Dose Pack	SY	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169319	alpelisib 200 MG (28) Oral Tablet / alpelisib 50 MG Oral Tablet (28) Oral Tablet, 250 MG Daily Dose Pack	SY	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169311	alpelisib 200 MG Oral Tablet, 200 MG Daily Dose Pack	SY	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169307	Piqray 150 MG Oral Tablet	SY	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169314	Piqray 200 MG Daily Dose Pack	SY	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169313	Piqray 200 MG Oral Tablet	SY	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169320	Piqray 250 MG Daily Dose Pack	SY	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169322	Piqray 300 MG Daily Dose Pack	SY	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13
2169318	Piqray 50 MG Oral Tablet	SY	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0715-02	00078071502	2 KIT in 1 CARTON (0078-0715-02) / 1 KIT in 1 KIT (0078-0715-61) * 14 TABLET in 1 BLISTER PACK * 14 TABLET in 1 BLISTER PACK	2 kit	2019-05-24	0000-00-00	No	No	Current
0078-0715-61	00078071561	1 in 1 KIT						Historical
0078-0715-91	00078071591	1 KIT in 1 CARTON (0078-0715-91) / 1 KIT in 1 KIT (0078-0715-94) * 14 TABLET in 1 BLISTER PACK * 14 TABLET in 1 BLISTER PACK	1 kit	2019-05-24	0000-00-00	Yes	No	Current
0078-0715-94	00078071594	1 in 1 KIT						Historical