Vanflyta (quizartinib) NDC 65597-511

NDC codes

FDA NDC Directory

Product NDC (as listed)65597-511Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65597-0511Add 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
65597-511-04	65597051104	1 BOTTLE in 1 CARTON (65597-511-04) / 14 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 20, 2023
65597-511-28	65597051128	1 BOTTLE in 1 CARTON (65597-511-28) / 28 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 20, 2023

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): Vanflyta
Generic name (nonproprietary): quizartinib
Active ingredients: Quizartinib dihydrochloride — 26.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Daiichi Sankyo Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 216993
Marketing start: Jul 20, 2023
Listing expires: Dec 31, 2027
Other FDA classes: FMS-like Receptor Tyrosine Kinase 3 (FLT3) Inhibitors (Mechanism)
Identifiers: Product ID 65597-511_ee05ebbe-cace-4b2f-bb89-c26687c1eeafSPL ID ee05ebbe-cace-4b2f-bb89-c26687c1eeafSPL set ID 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86RxCUI 2643054, 2643060, 2643062, 2643064UNII WK7Q6ZIZ10
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

N465597051104 followed by a unit qualifier and the quantity

Package 65597-0511-04. 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 Apr 16, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1) and Clinical Studies (14) ] . VANFLYTA is a kinase inhibitor indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 216993

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

FDA NDC Directory listings under NDA 216993
Product	Strength	Form · route	Labeler	Product NDC
Vanflytaquizartinib	Quizartinib dihydrochloride 17.7 mg/1	Tablet, Film coatedOral	Daiichi Sankyo Inc.	65597-504