Prescription drug · NDA
Fotivda (Tivozanib) NDC 45629-134
Tivozanib hydrochloride 1.34 mg/1 · Capsule · Oral · AVEO Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45629-134-02 | 45629013402 | 1 BOTTLE, PLASTIC in 1 CARTON (45629-134-02) / 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 — 1.34 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AVEO Pharmaceuticals, Inc.NDC labeler code 45629
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212904
- Marketing start
- Listing expires
- Other FDA classes
- Tyrosine Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 45629-134_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
N445629013402followed by a unit qualifier and the quantityPackage 45629-0134-02. 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.
About NDC 45629-134
- What is NDC 45629-134?
- 45629-134 is the product NDC for Fotivda (tivozanib), Tivozanib hydrochloride 1.34 mg/1 capsule, listed with the FDA by AVEO Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fotivda (Tivozanib).
- What is the active ingredient?
- Tivozanib hydrochloride.
- Who is the labeler?
- AVEO Pharmaceuticals, Inc., NDC labeler code 45629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fotivda?
- 1 other product NDC are listed under this name. See all Fotivda NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fotivda products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fotivdativozanib | Tivozanib hydrochloride .89 mg/1 | CapsuleOral | AVEO Pharmaceuticals, Inc. | 45629-089 | 45629-0089-02 |
Other NDCs under NDA 212904
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fotivdativozanib | Tivozanib hydrochloride .89 mg/1 | CapsuleOral | AVEO Pharmaceuticals, Inc. | 45629-089 |