Sunitinib Malate
- Product NDC
- 82293-016
- 11-digit product format
- 822930016
- Labeler code
- 82293
- Product ID
- 82293-016_21d0ff80-d937-abb3-e063-6394a90af4b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sunitinib Malate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Novugen Pharma (USA) LLC.
- Application
- ANDA218012
- Marketing category
- ANDA
- Marketing start
- 2024-05-01
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sunitinib Malate
- Listing expiration
- 2026-12-31
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 |
|---|
| 82293-016-10 | 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 |
|---|
| 82293-016 | SUNITINIB MALATE CAPSULE [NOVUGEN PHARMA (USA) LLC.] | 2 | Current NDC, 1 package rows | 20240912_04d34bce-1296-d2b9-e063-6394a90a7018.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 |
|---|
| 82293-016-10 | 82293001610 | 28 CAPSULE in 1 BOTTLE (82293-016-10) | 28 capsule | 2024-05-01 | No | No | Historical |