Prescription drug · NDA
Quviviq (Daridorexant) NDC 80491-7850
Daridorexant 50 mg/1 · Tablet, Film coated · Oral · Idorsia Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80491-7850-2 | 80491785002 | 1 BLISTER PACK in 1 CARTON (80491-7850-2) / 7 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 1, 2023 · Sample package | |
| 80491-7850-3 | 80491785003 | 1 BOTTLE in 1 CARTON (80491-7850-3) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 7, 2022 |
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)
- Quviviq
- Generic name (nonproprietary)
- daridorexant
- Active ingredients
- Daridorexant — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Idorsia Pharmaceuticals LtdNDC labeler code 80491
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214985
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Orexin Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 80491-7850_10e24e38-5645-433d-a160-82f4ed5b6dfbSPL ID 10e24e38-5645-433d-a160-82f4ed5b6dfbSPL set ID 3a2d1503-b816-40c9-9fac-7e03c5a3bcefRxCUI 2591502, 2591508, 2599096, 2599098UNII LMQ24G57E9
- Pharmacologic class
- Orexin 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
N480491785002followed by a unit qualifier and the quantityPackage 80491-7850-02. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
QUVIVIQ is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1) ] . QUVIVIQ is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 80491-7850
- What is NDC 80491-7850?
- 80491-7850 is the product NDC for Quviviq (daridorexant), Daridorexant 50 mg/1 tablet, film coated, listed with the FDA by Idorsia Pharmaceuticals Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quviviq (Daridorexant).
- What is the active ingredient?
- Daridorexant.
- Who is the labeler?
- Idorsia Pharmaceuticals Ltd, NDC labeler code 80491. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Quviviq?
- 1 other product NDC are listed under this name. See all Quviviq NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quviviq products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Quviviqdaridorexant | Daridorexant 25 mg/1 | Tablet, Film coatedOral | Idorsia Pharmaceuticals Ltd | 80491-7825 | 80491-7825-0280491-7825-03 |
Other NDCs under NDA 214985
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 |
|---|---|---|---|---|
| Quviviqdaridorexant | Daridorexant 25 mg/1 | Tablet, Film coatedOral | Idorsia Pharmaceuticals Ltd | 80491-7825 |