Fotivda (tivozanib) NDC 45629-089

NDC codes

FDA NDC Directory

Product NDC (as listed)45629-089Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45629-0089Add 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
45629-089-02	45629008902	1 BOTTLE, PLASTIC in 1 CARTON (45629-089-02) / 21 CAPSULE in 1 BOTTLE, PLASTICMarketed from Jan 30, 2025

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): Fotivda
Generic name (nonproprietary): tivozanib
Active ingredients: Tivozanib hydrochloride — .89 mg/1
Dosage form: Capsule
Route: Oral
Labeler: AVEO Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 212904
Marketing start: Mar 10, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Tyrosine Kinase Inhibitors (Mechanism)
Identifiers: Product ID 45629-089_c0014d0b-5a17-4280-8437-09e3f08e3625SPL ID c0014d0b-5a17-4280-8437-09e3f08e3625
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

N445629008902 followed by a unit qualifier and the quantity

Package 45629-0089-02. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under NDA 212904

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

FDA NDC Directory listings under NDA 212904
Product	Strength	Form · route	Labeler	Product NDC
Fotivdativozanib	Tivozanib hydrochloride 1.34 mg/1	CapsuleOral	AVEO Pharmaceuticals, Inc.	45629-134