Sunitinib Malate
- Product NDC
- 42291-903
- 11-digit product format
- 422910903
- Labeler code
- 42291
- Product ID
- 42291-903_4884360d-03d2-1af6-e063-6294a90aedf6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sunitinib Malate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA213803
- Marketing category
- ANDA
- Marketing start
- 2023-10-11
- Substance
- SUNITINIB MALATE
- Active strength
- 37.5 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
- Sunitinib Malate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SUNITINIB MALATE | 37.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LVX8N1UT73 |
| Rxcui | 616279, 616285, 616289, 1541890 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-903-28 | Sunitinib Malate | 28 in 1 BOTTLE | CAPSULE | 28 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-903 | SUNITINIB MALATE CAPSULE [AVKARE] | 1 | Current NDC, 1 package rows | 20231012_0772eb61-ca42-39de-e063-6294a90a6632.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-903-28 | 42291090328 | 28 CAPSULE in 1 BOTTLE (42291-903-28) | 28 capsule | 2023-10-11 | No | No | Current |