What is NDC 0078-0694?

0078-0694 is the product NDC for Zykadia (ceritinib), Ceritinib 150 mg/1 tablet, film coated, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, 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 Zykadia?

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.

Zykadia NDC 0078-0694 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-0694Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-0694Add 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
0078-0694-48	00078069448	21 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48)Marketed from Mar 18, 2019 · Sample package
0078-0694-84	00078069484	84 TABLET, FILM COATED in 1 BOTTLE (0078-0694-84)Marketed from Mar 18, 2019

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): Zykadia
Generic name (nonproprietary): ceritinib
Active ingredients: Ceritinib — 150 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Novartis Pharmaceuticals CorporationNDC labeler code 0078
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 211225
Marketing start: Mar 18, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Tyrosine Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0078-0694_8c405b95-6d3c-4bc5-9b01-2feb80903756SPL ID 8c405b95-6d3c-4bc5-9b01-2feb80903756SPL set ID fff5d805-4ffd-4e8e-8e63-6f129697563eRxCUI 2121059, 2121061UNII K418KG2GET
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

N400078069448 followed by a unit qualifier and the quantity

Package 00078-0694-48. 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 Dec 15, 2025.

Indications (excerpt from the label)

ZYKADIA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1)] . ZYKADIA is a kinase inhibitor indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. ( 1 , 2.1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0078-0694

What is NDC 0078-0694?: 0078-0694 is the product NDC for Zykadia (ceritinib), Ceritinib 150 mg/1 tablet, film coated, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zykadia (Ceritinib).
What is the active ingredient?: Ceritinib.
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 Zykadia?: 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.

Zykadia (Ceritinib) NDC 0078-0694