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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| G873GX646R | LAPATINIB DITOSYLATE | 388082-78-8 | LAPATINIB DITOSYLATE |
| 0VUA21238F | LAPATINIB | 231277-92-2 | Lapatinib |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0480-3237-51 | 00480323751 | 150 TABLET, FILM COATED in 1 BOTTLE (0480-3237-51) | 2024-12-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lapatinib | AvKARE | 2025-03-12 | HUMAN PRESCRIPTION DRUG LABEL | 1 |
| Lapatinib | Teva Pharmaceuticals, Inc. | 2023-11-30 | HUMAN PRESCRIPTION DRUG LABEL | 7 |