What is NDC 0078-0671?

0078-0671 is the product NDC for Tykerb (lapatinib), Lapatinib ditosylate 250 mg/1 tablet, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tykerb?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tykerb NDC 0078-0671 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-0671Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-0671Add 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
0078-0671-19	00078067119	150 TABLET in 1 BOTTLE (0078-0671-19)Marketed from Aug 3, 2016

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): Tykerb
Generic name (nonproprietary): lapatinib
Active ingredients: Lapatinib ditosylate — 250 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Novartis Pharmaceuticals CorporationNDC labeler code 0078
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022059
Marketing start: Aug 3, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0078-0671_940eccaf-92b4-4562-8579-24a53c1bc48dSPL ID 940eccaf-92b4-4562-8579-24a53c1bc48dSPL set ID eee37f88-ec6a-4c30-b8aa-e2c71f93088cRxCUI 672149, 672152UNII 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

N400078067119 followed by a unit qualifier and the quantity

Package 00078-0671-19. 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 Jan 27, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

TYKERB ® is 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 TYKERB 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. TYKERB in combination with an aromatase inhibitor has not been com…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0078-0671

What is NDC 0078-0671?: 0078-0671 is the product NDC for Tykerb (lapatinib), Lapatinib ditosylate 250 mg/1 tablet, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tykerb (Lapatinib).
What is the active ingredient?: Lapatinib ditosylate.
Who is the labeler?: Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tykerb?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Tykerb (Lapatinib) NDC 0078-0671