FDA.reportPublic FDA data

PIQRAY

Product NDC
0078-0708
11-digit product format
000780708
Labeler code
0078
Product ID
0078-0708_b4a9e0a0-a882-485b-918f-7134992246ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alpelisib
Dosage form
TABLET
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA212526
Marketing category
NDA
Marketing start
2019-05-24
Substance
ALPELISIB
Active strength
150 mg/1
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPELISIB150 mg/1

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
0078-0708-022023-08-01C16284748780-10191ceaa-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
0078-0708-912023-08-01C16284748780-10191ceaa-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
0078-0708-022023-07-28C16284748780-10191ceaa-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
0078-0708-912023-07-28C16284748780-10191ceaa-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
0078-0708-02PIQRAY2 in 1 CARTONTABLET213
0078-0708-51PIQRAY28 in 1 BLISTER PACKTABLET2813
0078-0708-90PIQRAY28 in 1 BLISTER PACKTABLET2813
0078-0708-91PIQRAY1 in 1 CARTONTABLET113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0708-02EA - Each0078-070880d29d7c-d712-4792-80c8-2c5bb2dbec3a12019-06-19
0078-0708-51EA - Each0078-070880ff57fe-3cff-42f7-810e-03196786e8f612019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0708PIQRAY (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
0078-0708-02000780708022 BLISTER PACK in 1 CARTON (0078-0708-02) / 28 TABLET in 1 BLISTER PACK (0078-0708-51) 2 blister pack2019-05-240000-00-00NoNoCurrent
0078-0708-510007807085128 in 1 BLISTER PACKHistorical
0078-0708-900007807089028 in 1 BLISTER PACKHistorical
0078-0708-91000780708911 BLISTER PACK in 1 CARTON (0078-0708-91) / 28 TABLET in 1 BLISTER PACK (0078-0708-90) 1 blister pack2019-05-240000-00-00YesNoCurrent