Prescription drug · ANDA
Dasatinib NDC 0480-3524
Dasatinib 140 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-3524-56 | 0048035245600480352456 | 30 TABLET, FILM COATED in 1 BOTTLE (0480-3524-56)Marketed from Sep 18, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 140 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Teva Pharmaceuticals, Inc.NDC labeler code 0480
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211094
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inhibitors (Mechanism)Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0480-3524_97769ebd-872d-4851-bf3f-51630e995dd6SPL ID 97769ebd-872d-4851-bf3f-51630e995dd6SPL set ID 3000fd91-1b09-4d72-8522-1ca5e35ed956RxCUI 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
N400480352456followed by a unit qualifier and the quantityPackage 00480-3524-56. 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.
About NDC 0480-3524
- What is NDC 0480-3524?
- 0480-3524 is the product NDC for Dasatinib, Dasatinib 140 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dasatinib.
- What is the active ingredient?
- Dasatinib.
- Who is the labeler?
- Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dasatinib?
- 95 other product NDCs are listed under this name. See all Dasatinib NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dasatinib products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dasatinib | Dasatinib 20 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-192 | 82009-0192-60 |
| Dasatinib | Dasatinib 100 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-196 | 82009-0196-30 |
| Dasatinib | Dasatinib 50 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-193 | 82009-0193-60 |
| Dasatinib | Dasatinib 70 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-194 | 82009-0194-60 |
| Dasatinib | Dasatinib 80 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-195 | 82009-0195-30 |
| Dasatinib | Dasatinib 140 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-197 | 82009-0197-30 |
| Dasatinib | Dasatinib 20 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-319 | 72205-0319-60 |
| Dasatinib | Dasatinib 100 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-323 | 72205-0323-30 |
| Dasatinib | Dasatinib 50 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-320 | 72205-0320-60 |
| Dasatinib | Dasatinib 70 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-321 | 72205-0321-60 |
Other NDCs under ANDA 211094
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 | Teva Pharmaceuticals, Inc. | 0480-3523 |
| Dasatinib | Dasatinib 20 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-5101 |
| Dasatinib | Dasatinib 50 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-5102 |
| Dasatinib | Dasatinib 70 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-5103 |
| Dasatinib | Dasatinib 100 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-5104 |
| Dasatinib | Dasatinib 20 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-046 |
| Dasatinib | Dasatinib 50 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-047 |
| Dasatinib | Dasatinib 70 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-048 |
| Dasatinib | Dasatinib 80 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-049 |
| Dasatinib | Dasatinib 100 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-050 |
| Dasatinib | Dasatinib 140 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-051 |