FDA.reportPublic FDA data

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

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii08W5N2C97Q
Rxcui2169300, 2169307, 2169310, 2169311, 2169313, 2169314, 2169316, 2169318, 2169319, 2169320, 2169321, 2169322

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
0078-0715-022023-08-01C16284748780-10191ceaa-6863-198a-e063-dbdaa90aec3eThese 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
0078-0715-912023-08-01C16284748780-10191ceaa-6863-198a-e063-dbdaa90aec3eThese 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
0078-0715-022023-07-28C16284748780-10191ceaa-6863-198a-e063-dbdaa90aec3eThese 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
0078-0715-912023-07-28C16284748780-10191ceaa-6863-198a-e063-dbdaa90aec3eThese 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 NDCProductDescriptionFormQuantityStrengthSPL version
0078-0715-02PIQRAY2 in 1 CARTONKIT213
0078-0715-61PIQRAY1 in 1 KITKIT113
0078-0715-91PIQRAY1 in 1 CARTONKIT113
0078-0715-94PIQRAY1 in 1 KITKIT113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0715-02EA - Each0078-0715c5b7efef-0ca0-4dba-9521-ae4c4dd078ac12019-06-19
0078-0715-61EA - Each0078-0715352f109c-026a-4927-830b-f3c6e15d683212019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0715PIQRAY (ALPELISIB) TABLET PIQRAY (ALPELISIB) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]12Current NDC, Legacy NDC, 4 package rows20250223_b20b4e18-7a4b-4500-a08f-06c6dab0ee5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2169314{28 (alpelisib 200 MG Oral Tablet [Piqray]) } Pack [Piqray 200 MG Daily Dose]BPCKb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169320{28 (alpelisib 200 MG Oral Tablet [Piqray]) / 28 (alpelisib 50 MG Oral Tablet [Piqray]) } Pack [Piqray 250 MG Daily Dose]BPCKb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169322{56 (alpelisib 150 MG Oral Tablet [Piqray]) } Pack [Piqray 300 MG Daily Dose]BPCKb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169311{28 (alpelisib 200 MG Oral Tablet) } PackGPCKb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169319{28 (alpelisib 200 MG Oral Tablet) / 28 (alpelisib 50 MG Oral Tablet) } PackGPCKb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169321{56 (alpelisib 150 MG Oral Tablet) } PackGPCKb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169321alpelisib 150 MG (56) Oral Tablet, 300 MG Daily Dose PackPSNb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169300alpelisib 150 MG Oral TabletPSNb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169319alpelisib 200 MG (28) Oral Tablet / alpelisib 50 MG Oral Tablet (28) Oral Tablet, 250 MG Daily Dose PackPSNb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169311alpelisib 200 MG (28) Oral Tablet, 200 MG Daily Dose PackPSNb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169310alpelisib 200 MG Oral TabletPSNb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169316alpelisib 50 MG Oral TabletPSNb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169307PIQRAY 150 MG Oral TabletPSNb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169314PIQRAY 200 MG Daily Dose PackPSNb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169313PIQRAY 200 MG Oral TabletPSNb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169320PIQRAY 250 MG Daily Dose PackPSNb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169322PIQRAY 300 MG Daily Dose PackPSNb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169318PIQRAY 50 MG Oral TabletPSNb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169307alpelisib 150 MG Oral Tablet [Piqray]SBDb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169313alpelisib 200 MG Oral Tablet [Piqray]SBDb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169318alpelisib 50 MG Oral Tablet [Piqray]SBDb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169300alpelisib 150 MG Oral TabletSCDb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169310alpelisib 200 MG Oral TabletSCDb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169316alpelisib 50 MG Oral TabletSCDb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169321alpelisib 150 MG (56) Oral Tablet, 300 MG Daily Dose PackSYb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169319alpelisib 200 MG (28) Oral Tablet / alpelisib 50 MG Oral Tablet (28) Oral Tablet, 250 MG Daily Dose PackSYb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169311alpelisib 200 MG Oral Tablet, 200 MG Daily Dose PackSYb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169307Piqray 150 MG Oral TabletSYb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169314Piqray 200 MG Daily Dose PackSYb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169313Piqray 200 MG Oral TabletSYb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169320Piqray 250 MG Daily Dose PackSYb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169322Piqray 300 MG Daily Dose PackSYb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13
2169318Piqray 50 MG Oral TabletSYb20b4e18-7a4b-4500-a08f-06c6dab0ee5b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0715-02000780715022 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 PACK2 kit2019-05-240000-00-00NoNoCurrent
0078-0715-61000780715611 in 1 KITHistorical
0078-0715-91000780715911 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 PACK1 kit2019-05-240000-00-00YesNoCurrent
0078-0715-94000780715941 in 1 KITHistorical