FDA.reportPublic FDA data

Lapatinib

Product NDC
0480-3237
11-digit product format
004803237
Labeler code
0480
Product ID
0480-3237_f259a366-78fc-4919-9bcb-748314a0581c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lapatinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA217968
Marketing category
ANDA
Marketing start
2024-12-19
Substance
LAPATINIB DITOSYLATE
Active strength
250 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Protein 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
Lapatinib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAPATINIB DITOSYLATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG873GX646R
Rxcui672149

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5e802855-bae9-a3e9-f938-a726f169ef05Product name320250317
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-3237-51Lapatinib150 in 1 BOTTLETABLET, FILM COATED1507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-3237-51EA - Each0480-32378cb744c1-107d-4cd2-b214-cdd03be1576412025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-3237LAPATINIB TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.]7Current NDC, 1 package rows20250101_b09abf73-1eef-4e12-b400-c030d546d223.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
672149lapatinib 250 MG Oral TabletPSNb09abf73-1eef-4e12-b400-c030d546d2237
672149lapatinib 250 MG Oral TabletSCDb09abf73-1eef-4e12-b400-c030d546d2237
672149lapatinib 250 MG (as lapatinib ditosylate 398 MG) Oral TabletSYb09abf73-1eef-4e12-b400-c030d546d2237
672149lapatinib 250 MG Oral TabletPSN302a4346-a68d-af3e-e063-6294a90a4a6f1
672149lapatinib 250 MG Oral TabletSCD302a4346-a68d-af3e-e063-6294a90a4a6f1
672149lapatinib 250 MG (as lapatinib ditosylate 398 MG) Oral TabletSY302a4346-a68d-af3e-e063-6294a90a4a6f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-3237-5100480323751150 TABLET, FILM COATED in 1 BOTTLE (0480-3237-51) 2024-12-19NoNoCurrent