What is NDC 42806-185?

42806-185 is the product NDC for 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.

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 Nystatin Topical Powder?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nystatin Topical Powder NDC 42806-185

NDC codes

FDA NDC Directory

Product NDC (as listed)42806-185Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42806-0185Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
42806-185-15	4280601851542806018515	15 g in 1 BOTTLE (42806-185-15)Marketed from Apr 14, 2023
42806-185-30	4280601853042806018530	30 g in 1 BOTTLE (42806-185-30)Marketed from Apr 14, 2023
42806-185-60	4280601856042806018560	60 g in 1 BOTTLE (42806-185-60)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): Nystatin Topical Powder
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: Apr 14, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Polyenes (Chemical structure)
Identifiers: Product ID 42806-185_8723c280-f501-46c5-8be5-8a3e9cbd28b9SPL ID 8723c280-f501-46c5-8be5-8a3e9cbd28b9SPL set ID fb2a480e-0bb1-445e-bbb6-701dea6dc631RxCUI 646456UNII BDF1O1C72EUPC 0342806185605, 0342806185155, 0342806185308
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

N442806018515 followed by a unit qualifier and the quantity

Package 42806-0185-15. 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 Aug 10, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42806-185

What is NDC 42806-185?: 42806-185 is the product NDC for 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?: 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 Nystatin Topical Powder?: 1 other product NDC are listed under this name. See all Nystatin Topical Powder NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nystatin Topical Powder NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nystatin Topical Powder	Nystatin 100000 U/g	PowderTopical	Epic Pharma, LLC	42806-178	42806-0178-1542806-0178-3042806-0178-60

Other NDCs under ANDA 210532

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 210532
Product	Strength	Form · route	Labeler	Product NDC
Klayestanystatin topical powder	Nystatin 100000 U/g	PowderTopical	Epic Pharma, LLC	42806-186
Nystatin Topical Powder	Nystatin 100000 U/g	PowderTopical	Epic Pharma, LLC	42806-178