Prescription drug · ANDA
Dasatinib NDC 46708-685
Dasatinib 50 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-685-60 | 46708068560 | 60 TABLET, FILM COATED in 1 BOTTLE (46708-685-60)Marketed from Nov 11, 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216261
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inhibitors (Mechanism)Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 46708-685_645fcf26-1b2f-40c5-881b-8effe02defbdSPL ID 645fcf26-1b2f-40c5-881b-8effe02defbdSPL set ID 645fcf26-1b2f-40c5-881b-8effe02defbdRxCUI 643105, 643107, 643109, 799047, 1045402, 1045406UNII RBZ1571X5HUPC 0346708684600
- 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
N446708068560followed by a unit qualifier and the quantityPackage 46708-0685-60. 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 tablet is 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 tablet is indicated for the treatment of pediatric patients 1 year of age and older with • Ph+ CML in chronic phase. Additional pediatric use information is approved for Bristol-Myers Squibb Company’s Sprycel (dasatinib) tablets. However, due to Bristol-Myers S…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216261
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 80 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-925 |
| Dasatinib | Dasatinib 20 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-922 |
| Dasatinib | Dasatinib 50 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-923 |
| Dasatinib | Dasatinib 70 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-924 |
| Dasatinib | Dasatinib 100 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-926 |
| Dasatinib | Dasatinib 140 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-927 |
| Dasatinib | Dasatinib 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-684 |
| Dasatinib | Dasatinib 100 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-688 |
| Dasatinib | Dasatinib 50 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-685 |
| Dasatinib | Dasatinib 70 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-686 |
| Dasatinib | Dasatinib 80 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-687 |
| Dasatinib | Dasatinib 140 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-689 |
| Dasatinib | Dasatinib 70 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-686 |
| Dasatinib | Dasatinib 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-684 |
| Dasatinib | Dasatinib 80 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-687 |
| Dasatinib | Dasatinib 100 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-688 |
| Dasatinib | Dasatinib 140 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-689 |