Prescription drug · NDA
Voydeya (Danicopan) NDC 25682-043
Danicopan 100 mg/1 · Tablet, Film coated · Oral · Alexion Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25682-043-92 | 25682004392 | 2 BOTTLE in 1 CARTON (25682-043-92) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 29, 2024 |
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)
- Voydeya
- Generic name (nonproprietary)
- danicopan
- Active ingredients
- Danicopan — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alexion Pharmaceuticals Inc.NDC labeler code 25682
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218037
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Complement Factor D Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 25682-043_cd0113b0-d5d6-4b03-9f6f-4d80bdcb71feSPL ID cd0113b0-d5d6-4b03-9f6f-4d80bdcb71feSPL set ID ab8d1cbd-a28b-4d49-82ab-5c7460719ac7RxCUI 2678957, 2678963, 2678965, 2678967, 2678972, 2678973, 2678974, 2678975UNII JM8C1SFX0U
- Pharmacologic class
- Complement Factor D 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
N425682004392followed by a unit qualifier and the quantityPackage 25682-0043-92. 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)
VOYDEYA is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). VOYDEYA is a complement factor D inhibitor indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH) ( 1 ). Limitations of Use VOYDEYA has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab. Limitations of Use VOYDEYA has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab.…
Excerpt only. Read the full label for complete information.
About NDC 25682-043
- What is NDC 25682-043?
- 25682-043 is the product NDC for Voydeya (danicopan), Danicopan 100 mg/1 tablet, film coated, listed with the FDA by Alexion Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Voydeya (Danicopan).
- What is the active ingredient?
- Danicopan.
- Who is the labeler?
- Alexion Pharmaceuticals Inc., NDC labeler code 25682. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Voydeya?
- 1 other product NDC are listed under this name. See all Voydeya NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Voydeya products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Voydeyadanicopan | — | Kit | Alexion Pharmaceuticals Inc. | 25682-046 | 25682-0046-92 |
Other NDCs under NDA 218037
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 |
|---|---|---|---|---|
| Voydeyadanicopan | — | Kit | Alexion Pharmaceuticals Inc. | 25682-046 |