Prescription drug · ANDA
Imatinib Mesylate NDC 60505-2901
Imatinib mesylate 400 mg/1 · Tablet, Film coated · Oral · Apotex Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-2901-0 | 60505290100 | 10 BLISTER PACK in 1 CARTON (60505-2901-0) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 5, 2016 | |
| 60505-2901-1 | 60505290101 | 100 TABLET, FILM COATED in 1 BOTTLE (60505-2901-1)Marketed from Aug 5, 2016 | |
| 60505-2901-3 | 60505290103 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-2901-3)Marketed from Aug 5, 2016 | |
| 60505-2901-5 | 60505290105 | 500 TABLET, FILM COATED in 1 BOTTLE (60505-2901-5)Marketed from Aug 5, 2016 | |
| 60505-2901-9 | 60505290109 | 90 TABLET, FILM COATED in 1 BOTTLE (60505-2901-9)Marketed from Aug 5, 2016 |
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)
- Imatinib Mesylate
- Generic name (nonproprietary)
- imatinib mesylate
- Active ingredients
- Imatinib mesylate — 400 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 079179
- 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 60505-2901_7560461e-a5f5-b4c8-c4c6-3145a0e98fdaSPL ID 7560461e-a5f5-b4c8-c4c6-3145a0e98fdaSPL set ID 0291eca5-7a1d-4a79-30be-252224d96509RxCUI 403878, 403879UNII 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
N460505290100followed by a unit qualifier and the quantityPackage 60505-2901-00. 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079179
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 | Apotex Corp | 60505-2900 |
| Imatinib Mesylate | Imatinib mesylate 100 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-882 |
| Imatinib Mesylate | Imatinib mesylate 400 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6621 |
| Imatinib Mesylate | Imatinib mesylate 100 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6901 |