Bosutinib NDC 46708-311

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-311Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0311Add 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
46708-311-35	46708031135	120 TABLET, FILM COATED in 1 BOTTLE (46708-311-35)Marketed from May 19, 2026

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): Bosutinib
Generic name (nonproprietary): bosutinib
Active ingredients: Bosutinib — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209543
Marketing start: May 19, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Bcr-Abl Tyrosine Kinase Inhibitors (Mechanism)
Identifiers: Product ID 46708-311_17a3b455-b49a-492d-b6dc-47e96e6037edSPL ID 17a3b455-b49a-492d-b6dc-47e96e6037edSPL set ID 8f3e9739-8ec1-4ea9-b1bc-185fd07d84e4RxCUI 1307624, 1307633UNII 5018V4AEZ0UPC 0346708311353, 0346708312305
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

N446708031135 followed by a unit qualifier and the quantity

Package 46708-0311-35. 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 May 22, 2026.

Indications (excerpt from the label)

Bosutinib tablets are indicated for the treatment of: • Adult patients with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), resistant or intolerant to prior therapy [see Clinical Studies (14.2)]. • Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)] . Pediatric use information is approved for PF PRISM CV’s BOSULIF® (bosutinib) tablets. However, due to PF PRISM CV’s marketing exclusivity rights, this drug product is not labeled with that information. Bosutinib is a kinase inhibitor indicated for the treatment of: • adult patients with chronic phase Ph+ …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209543

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

FDA NDC Directory listings under ANDA 209543
Product	Strength	Form · route	Labeler	Product NDC
Bosutinib	Bosutinib 500 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-312
Bosutinib	Bosutinib 100 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-311
Bosutinib	Bosutinib 500 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-312