What is NDC 68180-801?

68180-801 is the product NDC for Lapatinib, Lapatinib ditosylate 250 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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 68180-801 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68180-801Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68180-0801Add 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
68180-801-36	68180080136	150 TABLET in 1 BOTTLE (68180-801-36)Marketed from Sep 29, 2020

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
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.NDC labeler code 68180
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203007
Marketing start: Sep 29, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 68180-801_d331d11d-21f4-472c-82d9-3b03b582026aSPL ID d331d11d-21f4-472c-82d9-3b03b582026aSPL set ID 50d0dd0c-7682-43d0-aa1b-ca26e9181aeeRxCUI 672149UNII G873GX646RUPC 0368180801368
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

N468180080136 followed by a unit qualifier and the quantity

Package 68180-0801-36. 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 Jun 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Lapatinib tablets are kinase inhibitor indicated in combination with: ( 1 ) 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 capecetabine. 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 co…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68180-801

What is NDC 68180-801?: 68180-801 is the product NDC for Lapatinib, Lapatinib ditosylate 250 mg/1 tablet, listed with the FDA by Lupin 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?: Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3237	00480-3237-51