Lapatinib
- Product NDC
- 68180-801
- 11-digit product format
- 681800801
- Labeler code
- 68180
- Product ID
- 68180-801_d331d11d-21f4-472c-82d9-3b03b582026a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lapatinib
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA203007
- Marketing category
- ANDA
- Marketing start
- 2020-09-29
- 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 |
|---|
| 68180-801-36 | Lapatinib | 150 in 1 BOTTLE | TABLET | 150 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-801 | LAPATINIB TABLET [LUPIN PHARMACEUTICALS, INC. ] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231207_50d0dd0c-7682-43d0-aa1b-ca26e9181aee.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-801-36 | 68180080136 | 150 TABLET in 1 BOTTLE (68180-801-36) | 150 tablet | 2020-09-29 | 0000-00-00 | No | No | Current |