Prescription drug · ANDA
Klayesta (Nystatin topical powder) NDC 42806-186
Nystatin 100000 U/g · Powder · Topical · Epic Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-186-15 | 4280601861542806018615 | 15 g in 1 BOTTLE (42806-186-15)Marketed from Apr 14, 2023 | |
| 42806-186-30 | 4280601863042806018630 | 30 g in 1 BOTTLE (42806-186-30)Marketed from Apr 14, 2023 | |
| 42806-186-60 | 4280601866042806018660 | 60 g in 1 BOTTLE (42806-186-60)Marketed from Apr 14, 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)
- Klayesta
- Generic name (nonproprietary)
- nystatin topical powder
- Active ingredients
- Nystatin — 100000 U/g
- Dosage form
- Powder
- Route
- Topical
- Labeler
- Epic Pharma, LLCNDC labeler code 42806
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210532
- Marketing start
- Listing expires
- Other FDA classes
- Polyenes (Chemical structure)
- Identifiers
- Product ID 42806-186_d8220de7-25d0-46ba-b5a0-8f2f35bd5323SPL ID d8220de7-25d0-46ba-b5a0-8f2f35bd5323SPL set ID 0df13b1e-0e07-4123-a83a-1d7afb56170fRxCUI 646456UNII BDF1O1C72EUPC 0342806186305, 0342806186152
- Pharmacologic class
- Polyene Antifungal
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N442806018615followed by a unit qualifier and the quantityPackage 42806-0186-15. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE KLAYESTA is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. KLAYESTA is not indicated for systemic, oral, intravaginal or ophthalmic use.
Excerpt only. Read the full label for complete information.
About NDC 42806-186
- What is NDC 42806-186?
- 42806-186 is the product NDC for Klayesta (nystatin topical powder), Nystatin 100000 U/g powder, listed with the FDA by Epic Pharma, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Klayesta (Nystatin Topical Powder).
- What is the active ingredient?
- Nystatin.
- Who is the labeler?
- Epic Pharma, LLC, NDC labeler code 42806. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Klayesta?
- 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.
Other NDCs under ANDA 210532
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 |
|---|---|---|---|---|
| Nystatin Topical Powder | Nystatin 100000 U/g | PowderTopical | Epic Pharma, LLC | 42806-178 |
| Nystatin Topical Powder | Nystatin 100000 U/g | PowderTopical | Epic Pharma, LLC | 42806-185 |