Bosulif (bosutinib) NDC 0069-1014

NDC codes

FDA NDC Directory

Product NDC (as listed)0069-1014Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00069-1014Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0069-1014-15	00069101415	150 CAPSULE in 1 BOTTLE (0069-1014-15)Marketed from Jan 2, 2024

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): Bosulif
Generic name (nonproprietary): bosutinib
Active ingredients: Bosutinib monohydrate — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Pfizer Laboratories Div Pfizer Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 217729
Marketing start: Jan 2, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Bcr-Abl Tyrosine Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0069-1014_ca8600d9-46e6-402d-89f9-bc6a156bf751SPL ID ca8600d9-46e6-402d-89f9-bc6a156bf751SPL set ID adc84ad5-a04d-4fee-9ba8-91f7abd928e3RxCUI 1307624, 1307630, 1307633, 1307635, 1987732, 1987734, 2669663, 2669665, 2672326, 2672328UNII 844ZJE6I55UPC 0300691014158, 0300690504308, 0300690193014, 0300690136011, 0300690135014
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

N400069101415 followed by a unit qualifier and the quantity

Package 00069-1014-15. 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 Mar 10, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 217729

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 217729
Product	Strength	Form · route	Labeler	Product NDC
Bosulifbosutinib	Bosutinib monohydrate 50 mg/1	CapsuleOral	Pfizer Laboratories Div Pfizer Inc	0069-0504