Prescription drug · ANDA
Dasatinib NDC 60505-3816
Dasatinib 80 mg/1 · Tablet, Film coated · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-3816-3 | 60505381603 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-3816-3)Marketed from Sep 3, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 80 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Apotex Corp.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203180
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inhibitors (Mechanism)Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-3816_ec5a2f19-c89e-c4cd-c819-a22c585d18b4SPL ID ec5a2f19-c89e-c4cd-c819-a22c585d18b4SPL set ID 2ed87763-f018-abdb-c0ab-daa5e441b397RxCUI 643105, 643107, 643109, 799047, 1045402, 1045406UNII RBZ1571X5HUPC 0360505381630, 0360505363063
- 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
N460505381603followed by a unit qualifier and the quantityPackage 60505-3816-03. 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 diagnosed…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203180
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 140 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3817 |