Prescription drug · NDA
Imbruvica (ibrutinib) NDC 57962-420
Ibrutinib 420 mg/1 · Tablet, Film coated · Oral · Pharmacyclics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57962-420-28 | 57962042028 | 1 BLISTER PACK in 1 CARTON (57962-420-28) / 28 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 16, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Imbruvica
- Generic name (nonproprietary)
- ibrutinib
- Active ingredients
- Ibrutinib — 420 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Pharmacyclics LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210563
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 57962-420_43280dcb-52ae-40e4-bd52-723f71f74ab7SPL ID 43280dcb-52ae-40e4-bd52-723f71f74ab7SPL set ID 0dfd0279-ff17-4ea9-89be-9803c71bab44RxCUI 1442986, 1442992, 1994360, 1994362, 2000017, 2000019, 2000021, 2000023, 2000025, 2000027, 2611536, 2611540UNII 1X70OSD4VX
- 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
N457962042028followed by a unit qualifier and the quantityPackage 57962-0420-28. 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)
IMBRUVICA is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) ( 1.1 ). Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion ( 1.2 ). Adult patients with Waldenström’s macroglobulinemia (WM) ( 1.3 ). Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy ( 1.4 ). 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). 1. 2…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 210563
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.