FDA.reportPublic FDA data

Ayvakit

Product NDC
72064-125
11-digit product format
720640125
Labeler code
72064
Product ID
72064-125_5cf92ebf-46ff-4b14-becc-848ef1a79282
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
avapritinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blueprint Medicines Corporation
Application
NDA212608
Marketing category
NDA
Marketing start
2021-06-16
Substance
AVAPRITINIB
Active strength
25 mg/1
Pharmacologic classes
Bile Salt Export Pump Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Kinase Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Tyrosine Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVAPRITINIB25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii513P80B4YJ
Rxcui2272112, 2272118, 2272120, 2272122, 2272124, 2272126, 2559723, 2559725, 2559727, 2559729

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fce67a06-6367-4d5c-afb6-752e6ca352d3Product name220220118

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72064-125-302023-02-07C16284748780-1f386c649-9f6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AYVAKIT safely and effectively. See full prescribing information for AYVAKIT. AYVAKIT ® (avapritinib) tablets, for oral use Initial U.S. Approval: 2020
72064-125-302023-01-30C16284748780-1f386c649-9f6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AYVAKIT safely and effectively. See full prescribing information for AYVAKIT. AYVAKIT ® (avapritinib) tablets, for oral use Initial U.S. Approval: 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72064-125-30Ayvakit30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72064-125-30EA - Each72064-125013d8a99-8bfc-408e-9c6c-a5fe8ace5d6f12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72064-125AYVAKIT (AVAPRITINIB) TABLET, FILM COATED [BLUEPRINT MEDICINES CORPORATION]12Current NDC, Legacy NDC, 1 package rows20241121_645c887c-8cd4-4623-8da9-ac223d71a8b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2272112avapritinib 100 MG Oral TabletPSN645c887c-8cd4-4623-8da9-ac223d71a8b913
2272120avapritinib 200 MG Oral TabletPSN645c887c-8cd4-4623-8da9-ac223d71a8b913
2559723avapritinib 25 MG Oral TabletPSN645c887c-8cd4-4623-8da9-ac223d71a8b913
2272124avapritinib 300 MG Oral TabletPSN645c887c-8cd4-4623-8da9-ac223d71a8b913
2559727avapritinib 50 MG Oral TabletPSN645c887c-8cd4-4623-8da9-ac223d71a8b913
2272118AYVAKIT 100 MG Oral TabletPSN645c887c-8cd4-4623-8da9-ac223d71a8b913
2272122AYVAKIT 200 MG Oral TabletPSN645c887c-8cd4-4623-8da9-ac223d71a8b913
2559725AYVAKIT 25 MG Oral TabletPSN645c887c-8cd4-4623-8da9-ac223d71a8b913
2272126AYVAKIT 300 MG Oral TabletPSN645c887c-8cd4-4623-8da9-ac223d71a8b913
2559729AYVAKIT 50 MG Oral TabletPSN645c887c-8cd4-4623-8da9-ac223d71a8b913
2272118avapritinib 100 MG Oral Tablet [Ayvakit]SBD645c887c-8cd4-4623-8da9-ac223d71a8b913
2272122avapritinib 200 MG Oral Tablet [Ayvakit]SBD645c887c-8cd4-4623-8da9-ac223d71a8b913
2559725avapritinib 25 MG Oral Tablet [Ayvakit]SBD645c887c-8cd4-4623-8da9-ac223d71a8b913
2272126avapritinib 300 MG Oral Tablet [Ayvakit]SBD645c887c-8cd4-4623-8da9-ac223d71a8b913
2559729avapritinib 50 MG Oral Tablet [Ayvakit]SBD645c887c-8cd4-4623-8da9-ac223d71a8b913
2272112avapritinib 100 MG Oral TabletSCD645c887c-8cd4-4623-8da9-ac223d71a8b913
2272120avapritinib 200 MG Oral TabletSCD645c887c-8cd4-4623-8da9-ac223d71a8b913
2559723avapritinib 25 MG Oral TabletSCD645c887c-8cd4-4623-8da9-ac223d71a8b913
2272124avapritinib 300 MG Oral TabletSCD645c887c-8cd4-4623-8da9-ac223d71a8b913
2559727avapritinib 50 MG Oral TabletSCD645c887c-8cd4-4623-8da9-ac223d71a8b913
2272118Ayvakit 100 MG Oral TabletSY645c887c-8cd4-4623-8da9-ac223d71a8b913
2272122Ayvakit 200 MG Oral TabletSY645c887c-8cd4-4623-8da9-ac223d71a8b913
2559725Ayvakit 25 MG Oral TabletSY645c887c-8cd4-4623-8da9-ac223d71a8b913
2272126Ayvakit 300 MG Oral TabletSY645c887c-8cd4-4623-8da9-ac223d71a8b913
2559729Ayvakit 50 MG Oral TabletSY645c887c-8cd4-4623-8da9-ac223d71a8b913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72064-125-307206401253030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-125-30) 2021-06-160000-00-00NoNoCurrent