FDA.reportPublic FDA data

QINLOCK

Product NDC
73207-101
11-digit product format
732070101
Labeler code
73207
Product ID
73207-101_142c8672-a552-4d20-9226-2a92aa9773d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ripretinib
Dosage form
TABLET
Route
ORAL
Labeler
Deciphera Pharmaceuticals, LLC
Application
NDA213973
Marketing category
NDA
Marketing start
2020-05-15
Substance
RIPRETINIB
Active strength
50 mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], Platelet-derived Growth Factor alpha Receptor Inhibitors [MoA], Stem Cell Factor (KIT) Receptor 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
QINLOCK
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIPRETINIB50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9XW757O13D
Rxcui2369397, 2369403

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b5822ce0-4e78-4723-b738-8b73ca6586e4Product name120201008

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73207-101-302024-11-05C16284748780-11030e365-4d62-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use QINLOCK safely and effectively. See full prescribing information for QINLOCK. QINLOCK ® (ripretinib) tablets, for oral use Initial U.S. Approval: 2020
73207-101-312024-11-05C16284748780-11030e365-4d62-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use QINLOCK safely and effectively. See full prescribing information for QINLOCK. QINLOCK ® (ripretinib) tablets, for oral use Initial U.S. Approval: 2020
73207-101-302024-07-30C16284748780-11030e365-4d62-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use QINLOCK safely and effectively. See full prescribing information for QINLOCK. QINLOCK ® (ripretinib) tablets, for oral use Initial U.S. Approval: 2020
73207-101-312024-07-30C16284748780-11030e365-4d62-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use QINLOCK safely and effectively. See full prescribing information for QINLOCK. QINLOCK ® (ripretinib) tablets, for oral use Initial U.S. Approval: 2020
73207-101-302024-01-30C16284748780-11030e365-4d62-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use QINLOCK safely and effectively. See full prescribing information for QINLOCK. QINLOCK ® (ripretinib) tablets, for oral use Initial U.S. Approval: 2020
73207-101-312024-01-30C16284748780-11030e365-4d62-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use QINLOCK safely and effectively. See full prescribing information for QINLOCK. QINLOCK ® (ripretinib) tablets, for oral use Initial U.S. Approval: 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73207-101-30QINLOCK90 in 1 BOTTLETABLET909
73207-101-30QINLOCK1 in 1 CARTONTABLET19
73207-101-31QINLOCK30 in 1 BOTTLETABLET309
73207-101-31QINLOCK1 in 1 CARTONTABLET19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73207-101QINLOCK (RIPRETINIB) TABLET [DECIPHERA PHARMACEUTICALS, LLC ]9Current NDC, Legacy NDC, 4 package rows20250514_9f18e462-03dd-4296-a02a-a0577e3ee78d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2369403QINLOCK 50 MG Oral TabletPSN9f18e462-03dd-4296-a02a-a0577e3ee78d9
2369397ripretinib 50 MG Oral TabletPSN9f18e462-03dd-4296-a02a-a0577e3ee78d9
2369403ripretinib 50 MG Oral Tablet [Qinlock]SBD9f18e462-03dd-4296-a02a-a0577e3ee78d9
2369397ripretinib 50 MG Oral TabletSCD9f18e462-03dd-4296-a02a-a0577e3ee78d9
2369403Qinlock 50 MG Oral TabletSY9f18e462-03dd-4296-a02a-a0577e3ee78d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73207-101-30732070101301 BOTTLE in 1 CARTON (73207-101-30) / 90 TABLET in 1 BOTTLE1 bottle2020-05-150000-00-00NoNoCurrent
73207-101-31732070101311 BOTTLE in 1 CARTON (73207-101-31) / 30 TABLET in 1 BOTTLE1 bottle2020-05-150000-00-00YesNoCurrent