Prescription drug · ANDA
Dasatinib NDC 70377-084
Dasatinib 50 mg/1 · Tablet, Film coated · Oral · Biocon Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70377-084-11 | 70377008411 | 60 TABLET, FILM COATED in 1 BOTTLE (70377-084-11)Marketed from Mar 3, 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 — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Biocon Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217217
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inhibitors (Mechanism)Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 70377-084_6718ab7c-7205-4927-4055-0ce76dfca7acSPL ID 6718ab7c-7205-4927-4055-0ce76dfca7acSPL set ID 76e1833c-e105-5a3d-0f01-1330d8cc7ae1RxCUI 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
N470377008411followed by a unit qualifier and the quantityPackage 70377-0084-11. 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 217217
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 70 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-085 |
| Dasatinib | Dasatinib 20 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-083 |
| Dasatinib | Dasatinib 80 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-086 |
| Dasatinib | Dasatinib 100 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-087 |
| Dasatinib | Dasatinib 140 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-088 |
| Dasatinib | Dasatinib 50 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-661 |
| Dasatinib | Dasatinib 20 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-660 |
| Dasatinib | Dasatinib 100 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-664 |
| Dasatinib | Dasatinib 70 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-662 |
| Dasatinib | Dasatinib 80 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-663 |
| Dasatinib | Dasatinib 140 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-665 |