What is NDC 42291-035?

42291-035 is the product NDC for Lapatinib, Lapatinib ditosylate 250 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. 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 42291-035 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-035Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0035Add 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
42291-035-15	42291003515	150 TABLET, FILM COATED in 1 BOTTLE (42291-035-15)Marketed from Mar 12, 2025

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): Lapatinib
Generic name (nonproprietary): lapatinib
Active ingredients: Lapatinib ditosylate — 250 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217968
Marketing start: Mar 12, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 42291-035_302a4314-e1d6-3ce6-e063-6394a90a75a1SPL ID 302a4314-e1d6-3ce6-e063-6394a90a75a1SPL set ID 302a4346-a68d-af3e-e063-6294a90a4a6fRxCUI 672149UNII G873GX646RUPC 0342291035157
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

N442291003515 followed by a unit qualifier and the quantity

Package 42291-0035-15. 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 12, 2025. 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 42291-035

What is NDC 42291-035?: 42291-035 is the product NDC for Lapatinib, Lapatinib ditosylate 250 mg/1 tablet, film coated, listed with the FDA by AvKARE. 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?: AvKARE, NDC labeler code 42291. 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	Teva Pharmaceuticals, Inc.	0480-3237	00480-3237-51
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	Teva Pharmaceuticals, Inc.	0480-3237