Nystatin Topical Powder NDC 42806-178

NDC codes

FDA NDC Directory

Product NDC (as listed)42806-178Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42806-0178Add 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
42806-178-15	42806017815	15 g in 1 BOTTLE (42806-178-15)Marketed from May 2, 2018
42806-178-30	42806017830	30 g in 1 BOTTLE (42806-178-30)Marketed from May 2, 2018
42806-178-60	42806017860	60 g in 1 BOTTLE (42806-178-60)Marketed from May 2, 2018

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, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210532
Marketing start: May 2, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Polyenes (Chemical structure)
Identifiers: Product ID 42806-178_eb386427-9b1d-4b13-9e18-0f9cc00b4cb7SPL ID eb386427-9b1d-4b13-9e18-0f9cc00b4cb7SPL set ID 7f313a3b-7a4c-47fb-ad9f-e267514db527RxCUI 646456UNII BDF1O1C72E
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

N442806017815 followed by a unit qualifier and the quantity

Package 42806-0178-15. 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 May 2, 2018.

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)

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	42806-185