Prescription drug · NDA
Caprelsa (Vandetanib) NDC 58468-7840
Vandetanib 300 mg/1 · Tablet, Film coated · Oral · Genzyme Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58468-7840-3 | 5846878400358468784003 | 1 BOTTLE, PLASTIC in 1 CARTON (58468-7840-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Jul 25, 2011 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Caprelsa
- Generic name (nonproprietary)
- vandetanib
- Active ingredients
- Vandetanib — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Genzyme CorporationNDC labeler code 58468
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022405
- Marketing start
- Listing expires
- Other FDA classes
- Organic Cation Transporter 2 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 58468-7840_abb9eb38-c6a9-49e9-8e90-852f95773febSPL ID abb9eb38-c6a9-49e9-8e90-852f95773febSPL set ID e5721cb8-4185-47b9-bbb3-1c587e558a03RxCUI 1098416, 1098418, 1114074, 1114096UNII YO460OQ37K
- 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
N458468784003followed by a unit qualifier and the quantityPackage 58468-7840-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. CAPRELSA is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. ( 1 ) Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. ( 1 )…
Excerpt only. Read the full label for complete information.
About NDC 58468-7840
- What is NDC 58468-7840?
- 58468-7840 is the product NDC for Caprelsa (vandetanib), Vandetanib 300 mg/1 tablet, film coated, listed with the FDA by Genzyme Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Caprelsa (Vandetanib).
- What is the active ingredient?
- Vandetanib.
- Who is the labeler?
- Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Caprelsa?
- 1 other product NDC are listed under this name. See all Caprelsa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Caprelsa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Caprelsavandetanib | Vandetanib 100 mg/1 | Tablet, Film coatedOral | Genzyme Corporation | 58468-7820 | 58468-7820-03 |
Other NDCs under NDA 022405
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 |
|---|---|---|---|---|
| Caprelsavandetanib | Vandetanib 100 mg/1 | Tablet, Film coatedOral | Genzyme Corporation | 58468-7820 |