Prescription drug · ANDA
Imatinib Mesylate NDC 59651-241
Imatinib mesylate 400 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-241-03 | 59651024103 | 3 BLISTER PACK in 1 CARTON (59651-241-03) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 23, 2020 | |
| 59651-241-30 | 59651024130 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-241-30)Marketed from Jul 23, 2020 |
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 — 400 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212773
- Marketing start
- Listing expires
- Other FDA classes
- Bcr-Abl Tyrosine Kinase Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 59651-241_d00eefc8-50ef-494f-bcae-5b19329a9c7bSPL ID d00eefc8-50ef-494f-bcae-5b19329a9c7bSPL set ID a4e409f7-20b4-4c80-8a6a-f95995ffad78RxCUI 403878, 403879UNII 8A1O1M485BUPC 0359651240908, 0359651241301
- 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
N459651024103followed by a unit qualifier and the quantityPackage 59651-0241-03. 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)
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) Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. ( 1.4 ) Adult …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212773
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 | Imatinib mesylate 100 mg/1 | Tablet, Film coatedOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-086 |
| Imatinib Mesylate | Imatinib mesylate 400 mg/1 | Tablet, Film coatedOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-087 |
| Imatinib Mesylate | Imatinib mesylate 100 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-622 |
| Imatinib Mesylate | Imatinib mesylate 400 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-623 |
| Imatinib Mesylate | Imatinib mesylate 100 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-240 |