Kisqali (ribociclib) NDC 0078-0867

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-0867Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-0867Add 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
0078-0867-42	00078086742	3 BLISTER PACK in 1 CARTON (0078-0867-42) / 14 TABLET, FILM COATED in 1 BLISTER PACK (0078-0867-14)Marketed from Mar 13, 2017

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): Kisqali
Generic name (nonproprietary): ribociclib
Active ingredients: Ribociclib succinate — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Novartis Pharmaceuticals Corporation
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 209092
Marketing start: Mar 13, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 3A Inhibitors (Mechanism)Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0078-0867_9466e642-f230-43f3-b78e-5a432fa040eeSPL ID 9466e642-f230-43f3-b78e-5a432fa040eeSPL set ID aaeaef94-f3f5-4367-8ea2-b181d7be2da8RxCUI 1873983, 1873989, 1873990, 1873991, 1873992, 1873993, 1873994, 1873995UNII BG7HLX2919
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

N400078086742 followed by a unit qualifier and the quantity

Package 00078-0867-42. 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 Jul 1, 2026.

Indications (excerpt from the label)

KISQALI is a kinase inhibitor indicated: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. ( 1 ) for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. ( 1 ) 1.1 Early Breast Cancer KISQALI is indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults w…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 209092

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

FDA NDC Directory listings under NDA 209092
Product	Strength	Form · route	Labeler	Product NDC
Kisqaliribociclib	Ribociclib succinate 200 mg/1	Tablet, Film coatedOral	Novartis Pharmaceuticals Corporation	0078-0860
Kisqaliribociclib	Ribociclib succinate 200 mg/1	Tablet, Film coatedOral	Novartis Pharmaceuticals Corporation	0078-0874