Prescription drug · NDA
Filspari (Sparsentan) NDC 68974-400
Sparsentan 400 mg/1 · Tablet, Film coated · Oral · Travere Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68974-400-30 | 68974040030 | 30 TABLET, FILM COATED in 1 BOTTLE (68974-400-30)Marketed from Feb 17, 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)
- Filspari
- Generic name (nonproprietary)
- sparsentan
- Active ingredients
- Sparsentan — 400 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Travere Therapeutics, Inc.NDC labeler code 68974
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216403
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Type 1 Receptor Antagonists (Mechanism)Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Endothelin Receptor Antagonists (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 68974-400_2299f93e-22fc-48ac-8d06-c558fc57bb0dSPL ID 2299f93e-22fc-48ac-8d06-c558fc57bb0dSPL set ID d7354af1-f304-f4d9-e053-2995a90ab219RxCUI 2630540, 2630546, 2630548, 2630550UNII 9242RO5URM
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; 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
N468974040030followed by a unit qualifier and the quantityPackage 68974-0400-30. 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)
FILSPARI is an endothelin and angiotensin II receptor antagonist indicated: • To slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression ( 1.1 , 12.1 , 14.1 ). • To reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome ( 1.2 , 12.1 , 14.2 ). 1.1 Immunoglobulin A Nephropathy FILSPARI is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression [see Clinical Pharmacology ( 12.1 ), Clinical Studies ( 14.1 )]. 1.2 Focal Segmental Glomerulosclerosis FI…
Excerpt only. Read the full label for complete information.
About NDC 68974-400
- What is NDC 68974-400?
- 68974-400 is the product NDC for Filspari (sparsentan), Sparsentan 400 mg/1 tablet, film coated, listed with the FDA by Travere Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Filspari (Sparsentan).
- What is the active ingredient?
- Sparsentan.
- Who is the labeler?
- Travere Therapeutics, Inc., NDC labeler code 68974. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Filspari?
- 1 other product NDC are listed under this name. See all Filspari NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Filspari products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Filsparisparsentan | Sparsentan 200 mg/1 | Tablet, Film coatedOral | Travere Therapeutics, Inc. | 68974-200 | 68974-0200-30 |
Other NDCs under NDA 216403
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 |
|---|---|---|---|---|
| Filsparisparsentan | Sparsentan 200 mg/1 | Tablet, Film coatedOral | Travere Therapeutics, Inc. | 68974-200 |