Lapatinib
- Product NDC
- 42291-035
- 11-digit product format
- 422910035
- Labeler code
- 42291
- Product ID
- 42291-035_302a4314-e1d6-3ce6-e063-6394a90a75a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lapatinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA217968
- Marketing category
- ANDA
- Marketing start
- 2025-03-12
- 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| Ingredient | Strength |
|---|
| LAPATINIB DITOSYLATE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G873GX646R |
| Rxcui | 672149 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-035-15 | Lapatinib | 150 in 1 BOTTLE | TABLET, FILM COATED | 150 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-035 | LAPATINIB TABLET, FILM COATED [AVKARE] | 1 | Current NDC, 1 package rows | 20250315_302a4346-a68d-af3e-e063-6294a90a4a6f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-035-15 | 42291003515 | 150 TABLET, FILM COATED in 1 BOTTLE (42291-035-15) | 2025-03-12 | No | No | Historical |