Prescription drug · ANDA
Dasatinib NDC 43598-604
Dasatinib 140 mg/1 · Tablet, Film coated · Oral · Dr.Reddys Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-604-30 | 43598060430 | 30 TABLET, FILM COATED in 1 BOTTLE (43598-604-30)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 — 140 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Dr.Reddys Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213383
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inhibitors (Mechanism)Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 43598-604_ce9ef276-e0b1-4bd7-1e16-06035ef595a8SPL ID ce9ef276-e0b1-4bd7-1e16-06035ef595a8SPL set ID eb5ddff2-6521-b461-43ac-80ff8660b20bRxCUI 643105, 643107, 643109, 799047, 1045402, 1045406UNII RBZ1571X5HUPC 0343598604305, 0343598602301, 0343598599601
- 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
N443598060430followed by a unit qualifier and the quantityPackage 43598-0604-30. 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 is a kinase inhibitor indicated for the treatment of • newly dia…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213383
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 | Tablet, Film coatedOral | Dr.Reddys Laboratories Inc | 43598-600 |
| Dasatinib | Dasatinib 20 mg/1 | Tablet, Film coatedOral | Dr.Reddys Laboratories Inc | 43598-599 |
| Dasatinib | Dasatinib 100 mg/1 | Tablet, Film coatedOral | Dr.Reddys Laboratories Inc | 43598-603 |
| Dasatinib | Dasatinib 70 mg/1 | Tablet, Film coatedOral | Dr.Reddys Laboratories Inc | 43598-601 |
| Dasatinib | Dasatinib 80 mg/1 | Tablet, Film coatedOral | Dr.Reddys Laboratories Inc | 43598-602 |