Prescription drug · NDA
Vykat XR (Diazoxide choline) NDC 83860-025
Diazoxide choline 25 mg/1 · Tablet, Film coated · Oral · Soleno Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83860-025-01 | 83860002501 | 30 TABLET, FILM COATED in 1 BOTTLE (83860-025-01)Marketed from Mar 26, 2025 |
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)
- Vykat XR
- Generic name (nonproprietary)
- diazoxide choline
- Active ingredients
- Diazoxide choline — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Soleno Therapeutics, Inc.NDC labeler code 83860
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216665
- Marketing start
- Listing expires
- Identifiers
- Product ID 83860-025_b8413ebc-f835-4c45-9524-91bda45bd35fSPL ID b8413ebc-f835-4c45-9524-91bda45bd35fSPL set ID 0e745e85-9512-e360-e063-6394a90aebf1RxCUI 2711548, 2711556, 2711559, 2711562, 2711565, 2711568UNII 2U8NRZ7P8L
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
N483860002501followed by a unit qualifier and the quantityPackage 83860-0025-01. 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)
VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 83860-025
- What is NDC 83860-025?
- 83860-025 is the product NDC for Vykat XR (diazoxide choline), Diazoxide choline 25 mg/1 tablet, film coated, listed with the FDA by Soleno Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vykat XR (Diazoxide choline).
- What is the active ingredient?
- Diazoxide choline.
- Who is the labeler?
- Soleno Therapeutics, Inc., NDC labeler code 83860. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vykat XR?
- 2 other product NDCs are listed under this name. See all Vykat XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vykat XR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vykat XRdiazoxide choline | Diazoxide choline 75 mg/1 | Tablet, Film coatedOral | Soleno Therapeutics, Inc. | 83860-075 | 83860-0075-01 |
| Vykat XRdiazoxide choline | Diazoxide choline 150 mg/1 | Tablet, Film coatedOral | Soleno Therapeutics, Inc. | 83860-150 | 83860-0150-01 |
Other NDCs under NDA 216665
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 |
|---|---|---|---|---|
| Vykat XRdiazoxide choline | Diazoxide choline 75 mg/1 | Tablet, Film coatedOral | Soleno Therapeutics, Inc. | 83860-075 |
| Vykat XRdiazoxide choline | Diazoxide choline 150 mg/1 | Tablet, Film coatedOral | Soleno Therapeutics, Inc. | 83860-150 |