Prescription drug · ANDA
Imatinib Mesylate (Imatinib) NDC 0378-2245
Imatinib mesylate 100 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-2245-77 | 0037822457700378224577 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2245-77)Marketed from Sep 28, 2017 |
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
- Active ingredients
- Imatinib mesylate — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204644
- 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 0378-2245_fc5effad-71a0-4882-b026-5b73b2c3c526SPL ID fc5effad-71a0-4882-b026-5b73b2c3c526SPL set ID a1787fad-3612-43e1-98fa-ce62361e0b3cRxCUI 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
N400378224577followed by a unit qualifier and the quantityPackage 00378-2245-77. 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 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 chemoth…
Excerpt only. Read the full label for complete information.
About NDC 0378-2245
- What is NDC 0378-2245?
- 0378-2245 is the product NDC for Imatinib Mesylate (imatinib), Imatinib mesylate 100 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Imatinib Mesylate (Imatinib).
- What is the active ingredient?
- Imatinib mesylate.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 204644
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 Mesylateimatinib | Imatinib mesylate 400 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-2246 |
| Imatinib Mesylateimatinib | Imatinib mesylate 100 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc | 42292-043 |
| Imatinib Mesylateimatinib | Imatinib mesylate 400 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc | 42292-044 |
| Imatinib Mesylateimatinib | Imatinib mesylate 100 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-049 |
| Imatinib Mesylateimatinib | Imatinib mesylate 400 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-050 |
| Imatinib Mesylateimatinib | Imatinib mesylate 100 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-269 |
| Imatinib Mesylateimatinib | Imatinib mesylate 400 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-270 |