Prescription drug · ANDA
Bosutinib NDC 62332-311
Bosutinib 100 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-311-35 | 6233203113562332031135 | 120 TABLET, FILM COATED in 1 BOTTLE (62332-311-35)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 Inc.NDC labeler code 62332
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209543
- Marketing start
- Listing expires
- Other FDA classes
- Bcr-Abl Tyrosine Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 62332-311_45618427-a81b-436a-9326-8de755cb1eb9SPL ID 45618427-a81b-436a-9326-8de755cb1eb9SPL set ID 2ea1617f-41d3-479a-87d5-177013d39193RxCUI 1307624, 1307633UNII 5018V4AEZ0UPC 0362332311354, 0362332312306
- 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
N462332031135followed by a unit qualifier and the quantityPackage 62332-0311-35. 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 .
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.
About NDC 62332-311
- What is NDC 62332-311?
- 62332-311 is the product NDC for Bosutinib, Bosutinib 100 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bosutinib.
- What is the active ingredient?
- Bosutinib.
- Who is the labeler?
- Alembic Pharmaceuticals Inc., NDC labeler code 62332. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bosutinib?
- 4 other product NDCs are listed under this name. See all Bosutinib NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bosutinib products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bosutinib | Bosutinib 400 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 75907-405 | 75907-0405-30 |
| Bosutinib | Bosutinib 100 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-311 | 46708-0311-35 |
| Bosutinib | Bosutinib 500 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-312 | 46708-0312-30 |
| Bosutinib | Bosutinib 500 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-312 | 62332-0312-30 |
Other NDCs under ANDA 209543
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 |
|---|---|---|---|---|
| Bosutinib | Bosutinib 100 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-311 |
| Bosutinib | Bosutinib 500 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-312 |
| Bosutinib | Bosutinib 500 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-312 |