FDA.reportPublic FDA data

TYKERB

Product NDC
0078-0671
11-digit product format
000780671
Labeler code
0078
Product ID
0078-0671_940eccaf-92b4-4562-8579-24a53c1bc48d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lapatinib
Dosage form
TABLET
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA022059
Marketing category
NDA
Marketing start
2016-08-03
Substance
LAPATINIB DITOSYLATE
Active strength
250 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TYKERB
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAPATINIB DITOSYLATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG873GX646R
Rxcui672149, 672152

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5e802855-bae9-a3e9-f938-a726f169ef05Product name320250317

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0078-0671-192023-08-01C16284748780-10191ceaa-6bde-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use TYKERB safely and effectively. See full prescribing information for TYKERB. TYKERB ® (lapatinib) tablets, for oral use Initial U.S. Approval: 2007
0078-0671-192023-07-28C16284748780-10191ceaa-6bde-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use TYKERB safely and effectively. See full prescribing information for TYKERB. TYKERB ® (lapatinib) tablets, for oral use Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0671-19TYKERB150 in 1 BOTTLETABLET15014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0671-19EA - Each0078-0671d8565b5c-fe4d-4404-91e1-eaeb8608157112016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0671TYKERB (LAPATINIB) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]12Current NDC, Legacy NDC, 1 package rows20250112_eee37f88-ec6a-4c30-b8aa-e2c71f93088c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
672149lapatinib 250 MG Oral TabletPSNeee37f88-ec6a-4c30-b8aa-e2c71f93088c14
672152Tykerb 250 MG Oral TabletPSNeee37f88-ec6a-4c30-b8aa-e2c71f93088c14
672152lapatinib 250 MG Oral Tablet [Tykerb]SBDeee37f88-ec6a-4c30-b8aa-e2c71f93088c14
672149lapatinib 250 MG Oral TabletSCDeee37f88-ec6a-4c30-b8aa-e2c71f93088c14
672149lapatinib 250 MG (as lapatinib ditosylate 398 MG) Oral TabletSYeee37f88-ec6a-4c30-b8aa-e2c71f93088c14
672152Tykerb 250 MG Oral TabletSYeee37f88-ec6a-4c30-b8aa-e2c71f93088c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0671-1900078067119150 TABLET in 1 BOTTLE (0078-0671-19) 150 tablet2016-08-030000-00-00NoNoCurrent