Prescription drug · NDA
Gleevec (Imatinib mesylate) NDC 0078-0401
Imatinib mesylate 100 mg/1 · Tablet · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0401-34 | 00078040134 | 90 TABLET in 1 BOTTLE (0078-0401-34)Marketed from May 15, 2001 |
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)
- Gleevec
- Generic name (nonproprietary)
- imatinib mesylate
- Active ingredients
- Imatinib mesylate — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021588
- 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 0078-0401_2b30c65b-bf6e-4a30-9754-585d500d59f3SPL ID 2b30c65b-bf6e-4a30-9754-585d500d59f3SPL set ID 211ef2da-2868-4a77-8055-1cb2cd78e24bRxCUI 403878, 403879, 404588, 404589UNII 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
N400078040134followed by a unit qualifier and the quantityPackage 00078-0401-34. 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)
Gleevec 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 patien…
Excerpt only. Read the full label for complete information.
About NDC 0078-0401
- What is NDC 0078-0401?
- 0078-0401 is the product NDC for Gleevec (imatinib mesylate), Imatinib mesylate 100 mg/1 tablet, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gleevec (Imatinib mesylate).
- What is the active ingredient?
- Imatinib mesylate.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gleevec?
- 2 other product NDCs are listed under this name. See all Gleevec NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gleevec products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gleevecimatinib mesylate | Imatinib mesylate 400 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0649 | 00078-0649-1300078-0649-30 |
| Gleevecimatinib mesylate | Imatinib mesylate 400 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-1490 | 00078-1490-13 |
Other NDCs under NDA 021588
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 |
|---|---|---|---|---|
| Gleevecimatinib mesylate | Imatinib mesylate 400 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0649 |
| Gleevecimatinib mesylate | Imatinib mesylate 400 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-1490 |