Sunitinib Malate
- Product NDC
- 72205-116
- 11-digit product format
- 722050116
- Labeler code
- 72205
- Product ID
- 72205-116_15dd0555-b33f-4f56-94d3-0f4ce888df01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sunitinib Malate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA214824
- Marketing category
- ANDA
- Marketing start
- 2025-02-14
- Substance
- SUNITINIB MALATE
- Active strength
- 12.5 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 |
|---|---|
| SUNITINIB MALATE | 12.5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | LVX8N1UT73 |
| Rxcui | 616279, 616285, 616289, 1541890 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c71c27c5-81ab-f132-824f-21f56518b6f9 | Product name | 3 | 20250516 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72205-116-28 | Sunitinib Malate | 28 in 1 BOTTLE | CAPSULE | 28 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72205-116-28 | EA - Each | 72205-116 | 212bc8ba-deb5-40ac-99e5-b4a4f28bb980 | 1 | 2025-08-11 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 616279 | SUNItinib malate 12.5 MG Oral Capsule | PSN | 15dd0555-b33f-4f56-94d3-0f4ce888df01 | 1 |
| 616285 | SUNItinib malate 25 MG Oral Capsule | PSN | 15dd0555-b33f-4f56-94d3-0f4ce888df01 | 1 |
| 1541890 | SUNItinib malate 37.5 MG Oral Capsule | PSN | 15dd0555-b33f-4f56-94d3-0f4ce888df01 | 1 |
| 616289 | SUNItinib malate 50 MG Oral Capsule | PSN | 15dd0555-b33f-4f56-94d3-0f4ce888df01 | 1 |
| 616279 | sunitinib 12.5 MG Oral Capsule | SCD | 15dd0555-b33f-4f56-94d3-0f4ce888df01 | 1 |
| 616285 | sunitinib 25 MG Oral Capsule | SCD | 15dd0555-b33f-4f56-94d3-0f4ce888df01 | 1 |
| 1541890 | sunitinib 37.5 MG Oral Capsule | SCD | 15dd0555-b33f-4f56-94d3-0f4ce888df01 | 1 |
| 616289 | sunitinib 50 MG Oral Capsule | SCD | 15dd0555-b33f-4f56-94d3-0f4ce888df01 | 1 |
| 616285 | sunitinib (as sunitinib malate) 25 MG Oral Capsule | SY | 15dd0555-b33f-4f56-94d3-0f4ce888df01 | 1 |
| 1541890 | sunitinib (as sunitinib malate) 37.5 MG Oral Capsule | SY | 15dd0555-b33f-4f56-94d3-0f4ce888df01 | 1 |
| 616279 | sunitinib 12.5 MG (as sunitinib malate 16.7 MG) Oral Capsule | SY | 15dd0555-b33f-4f56-94d3-0f4ce888df01 | 1 |
| 616289 | sunitinib 50 MG (as sunitinib malate 66.8 MG) Oral Capsule | SY | 15dd0555-b33f-4f56-94d3-0f4ce888df01 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72205-116-28 | 72205011628 | 28 CAPSULE in 1 BOTTLE (72205-116-28) | 28 capsule | 2025-06-01 | No | No | Current |