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 | 00378224577 | 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.
- 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 | Golden State Medical Supply, Inc. | 51407-269 |
| Imatinib Mesylateimatinib | Imatinib mesylate 400 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-270 |
| 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 |