What is NDC 0480-3237?

0480-3237 is the product NDC for Lapatinib, Lapatinib ditosylate 250 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lapatinib?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lapatinib NDC 0480-3237 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0480-3237Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00480-3237Add 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
0480-3237-51	00480323751	150 TABLET, FILM COATED in 1 BOTTLE (0480-3237-51)Marketed from Dec 19, 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): Lapatinib
Generic name (nonproprietary): lapatinib
Active ingredients: Lapatinib ditosylate — 250 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Teva Pharmaceuticals, Inc.NDC labeler code 0480
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217968
Marketing start: Dec 19, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0480-3237_f259a366-78fc-4919-9bcb-748314a0581cSPL ID f259a366-78fc-4919-9bcb-748314a0581cSPL set ID b09abf73-1eef-4e12-b400-c030d546d223RxCUI 672149UNII G873GX646R
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

N400480323751 followed by a unit qualifier and the quantity

Package 00480-3237-51. 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 Nov 30, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Lapatinib tablets are indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with lapatinib tablets in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. Lapatinib tablets in combination with an arom…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0480-3237

What is NDC 0480-3237?: 0480-3237 is the product NDC for Lapatinib, Lapatinib ditosylate 250 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lapatinib.
What is the active ingredient?: Lapatinib ditosylate.
Who is the labeler?: Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lapatinib?: 2 other product NDCs are listed under this name. See all Lapatinib NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Lapatinib NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lapatinib	Lapatinib ditosylate 250 mg/1	Tablet, Film coatedOral	AvKARE	42291-035	42291-0035-15
Lapatinib	Lapatinib ditosylate 250 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-801	68180-0801-36

Other NDCs under ANDA 217968

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

FDA NDC Directory listings under ANDA 217968
Product	Strength	Form · route	Labeler	Product NDC
Lapatinib	Lapatinib ditosylate 250 mg/1	Tablet, Film coatedOral	AvKARE	42291-035