Prescription drug · ANDA
Dasatinib NDC 59651-546
Dasatinib 100 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-546-15 | 59651054615 | 1 BLISTER PACK in 1 CARTON (59651-546-15) / 15 TABLET in 1 BLISTER PACKMarketed from Apr 22, 2025 | |
| 59651-546-30 | 59651054630 | 30 TABLET in 1 BOTTLE (59651-546-30)Marketed from Apr 22, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Dasatinib
- Generic name (nonproprietary)
- dasatinib
- Active ingredients
- Dasatinib — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216547
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inhibitors (Mechanism)Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 59651-546_d0b613be-d8e5-4bcb-b41f-4bbd3509ab73SPL ID d0b613be-d8e5-4bcb-b41f-4bbd3509ab73SPL set ID 58ce42c6-10bd-4bb4-bf89-eae8ed82c339RxCUI 643105, 643107, 643109, 799047, 1045402, 1045406UNII RBZ1571X5H
- Pharmacologic class
- Kinase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459651054615followed by a unit qualifier and the quantityPackage 59651-0546-15. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. Dasatinib tablets are a kinase inhibitor indicated for the treatment of newly diagno…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216547
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dasatinib | Dasatinib 50 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-543 |
| Dasatinib | Dasatinib 20 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-542 |
| Dasatinib | Dasatinib 140 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-547 |
| Dasatinib | Dasatinib 70 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-544 |
| Dasatinib | Dasatinib 80 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-545 |