Prescription drug · ANDA
Imatinib mesylate NDC 72485-202
Imatinib mesylate 100 mg/1 · Tablet, Film coated · Oral · Armas Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72485-202-90 | 72485020290 | 90 TABLET, FILM COATED in 1 BOTTLE (72485-202-90)Marketed from Mar 15, 2019 |
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)
- Imatinib mesylate
- Generic name (nonproprietary)
- imatinib mesylate
- Active ingredients
- Imatinib mesylate — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Armas Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208302
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 72485-202_f3d17411-8424-4c6d-b244-47f125f17f31SPL ID f3d17411-8424-4c6d-b244-47f125f17f31SPL set ID 2e931c49-6c9f-41e2-a34b-5f01cd295b56RxCUI 403878UNII 8A1O1M485B
- 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
N472485020290followed by a unit qualifier and the quantityPackage 72485-0202-90. 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)
Imatinib mesylate is a kinase inhibitor indicated for the treatment of: Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase ( 1.1 ) Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy ( 1.2 ) Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) ( 1.3 ) Adult patients with myelodysplastic/ myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208302
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 |
|---|---|---|---|---|
| Imatinib mesylate 400 mgimatinib mesylate | Imatinib mesylate 400 mg/1 | Tablet, Film coatedOral | Armas Pharmaceuticals Inc. | 72485-203 |
| Imatinib mesylate | Imatinib mesylate 400 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-634 |
| Imatinib mesylate | Imatinib mesylate 100 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-633 |