Prescription drug · ANDA
imatinib mesylate NDC 0832-0533
Imatinib mesylate 400 mg/1 · Tablet · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-0533-03 | 0083205330300832053303 | 30 TABLET in 1 BOTTLE (0832-0533-03)Marketed from May 17, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Route
- Oral
- Labeler
- Upsher-Smith Laboratories, LLCNDC labeler code 0832
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212135
- Marketing start
- Marketing end
- Other FDA classes
- Bcr-Abl Tyrosine Kinase Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0832-0533_47f6137e-e0ea-4ada-e063-6394a90a37b5SPL ID 47f6137e-e0ea-4ada-e063-6394a90a37b5SPL set ID 5d07ac08-962e-41a8-8a3c-50febc8c5f34RxCUI 403878, 403879UNII 8A1O1M485BUPC 0308320533032
- 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
N400832053303followed by a unit qualifier and the quantityPackage 00832-0533-03. 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 tablets are 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…
Excerpt only. Read the full label for complete information.
About NDC 0832-0533
- What is NDC 0832-0533?
- 0832-0533 is the product NDC for imatinib mesylate, Imatinib mesylate 400 mg/1 tablet, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- imatinib mesylate.
- What is the active ingredient?
- Imatinib mesylate.
- Who is the labeler?
- Upsher-Smith Laboratories, LLC, NDC labeler code 0832. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for imatinib mesylate?
- 39 other product NDCs are listed under this name. See all imatinib mesylate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other imatinib mesylate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Imatinib Mesylate | Imatinib mesylate 100 mg/1 | Tablet, Film coatedOral | Civica Script LLC | 82249-020 | 82249-0020-90 |
| Imatinib Mesylate | Imatinib mesylate 400 mg/1 | Tablet, Film coatedOral | Civica Script LLC | 82249-021 | 82249-0021-30 |
| Imatinib Mesylateimatinib | Imatinib mesylate 100 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-049 | 48433-0049-03 |
| Imatinib Mesylateimatinib | Imatinib mesylate 400 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-050 | 48433-0050-03 |
| Imatinib Mesylate | Imatinib mesylate 100 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-296 | 31722-0296-90 |
| Imatinib Mesylate | Imatinib mesylate 400 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-297 | 31722-0297-30 |
| Imatinib Mesylate | Imatinib mesylate 100 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-882 | 60687-0882-21 |
| Imatinib Mesylate | Imatinib mesylate 100 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-622 | 68001-0622-05 |
| Imatinib Mesylate | Imatinib mesylate 400 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-623 | 68001-0623-04 |
| imatinib mesylate | Imatinib mesylate 100 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-0532 | 00832-0532-09 |
Other NDCs under ANDA 212135
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 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-0532 |
| imatinib mesylate | Imatinib mesylate 100 mg/1 | TabletOral | Qilu Pharmaceutical Co., Ltd. | 67184-0532 |
| imatinib mesylate | Imatinib mesylate 400 mg/1 | TabletOral | Qilu Pharmaceutical Co., Ltd. | 67184-0533 |
| imatinib mesylate | Imatinib mesylate 100 mg/1 | TabletOral | Archis Pharma LLC | 72819-185 |
| imatinib mesylate | Imatinib mesylate 400 mg/1 | TabletOral | Archis Pharma LLC | 72819-186 |