Prescription drug · NDA
Vanrafia (Atrasentan) NDC 0078-1420
Atrasentan hydrochloride .75 mg/1 · Tablet, Film coated · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-1420-15 | 00078142015 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-1420-15)Marketed from Apr 2, 2025 |
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)
- Vanrafia
- Generic name (nonproprietary)
- atrasentan
- Active ingredients
- Atrasentan hydrochloride — .75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219208
- Marketing start
- Listing expires
- Other FDA classes
- Endothelin Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0078-1420_48384e66-f6ff-4b6e-81e2-0a7ac05e8627SPL ID 48384e66-f6ff-4b6e-81e2-0a7ac05e8627SPL set ID 9a7e7f85-bfd0-44a0-beda-3bcfa8215c64RxCUI 2710454, 2710460UNII E4G31X93ZA
- Pharmacologic class
- Endothelin Receptor Antagonist
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
N400078142015followed by a unit qualifier and the quantityPackage 00078-1420-15. 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)
VANRAFIA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. This indication is approved under accelerated approval based on a reduction of proteinuria [see Clinical Studies (14.1)] . It has not been established whether VANRAFIA slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. VANRAFIA is an endothelin receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy…
Excerpt only. Read the full label for complete information.
About NDC 0078-1420
- What is NDC 0078-1420?
- 0078-1420 is the product NDC for Vanrafia (atrasentan), Atrasentan hydrochloride .75 mg/1 tablet, film coated, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vanrafia (Atrasentan).
- What is the active ingredient?
- Atrasentan hydrochloride.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vanrafia?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.