Prescription drug · NDA
Bosulif (bosutinib) NDC 63539-193
Bosutinib monohydrate 400 mg/1 · Tablet, Film coated · Oral · U.S. Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63539-193-30 | 63539019330 | 30 TABLET, FILM COATED in 1 BOTTLE (63539-193-30)Marketed from Feb 21, 2018 · Sample package |
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)
- Bosulif
- Generic name (nonproprietary)
- bosutinib
- Active ingredients
- Bosutinib monohydrate — 400 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- U.S. Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203341
- Marketing start
- Listing expires
- Other FDA classes
- Bcr-Abl Tyrosine Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 63539-193_18405060-7e60-4a8d-ad8f-cf6e338ec217SPL ID 18405060-7e60-4a8d-ad8f-cf6e338ec217SPL set ID d5929f91-6496-4c0e-97e8-0bd524e15763RxCUI 1307624, 1307630, 1987732, 1987734UNII 844ZJE6I55
- 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
N463539019330followed by a unit qualifier and the quantityPackage 63539-0193-30. 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)
BOSULIF is indicated for the treatment of: • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . • Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2) ] . BOSULIF is a kinase inhibitor indicated for the treatment of • adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. ( 1 ) …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 203341
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 |
|---|---|---|---|---|
| Bosulifbosutinib | Bosutinib monohydrate 100 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0135 |
| Bosulifbosutinib | Bosutinib monohydrate 400 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0193 |
| Bosulifbosutinib | Bosutinib monohydrate 500 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0136 |