Nystatin NDC 72189-278

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-278Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0278Add 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	Copy
72189-278-15	72189027815	15 g in 1 BOX (72189-278-15)Marketed from Sep 30, 2021

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
Generic name (nonproprietary): nystatin
Active ingredients: Nystatin — 100000 [USP'U]/g
Dosage form: Cream
Route: Oral, Topical
Labeler: DIRECT RX
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 064022
Marketing start: Sep 30, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Polyenes (Chemical structure)
Identifiers: Product ID 72189-278_2c290c08-d35f-21b4-e063-6394a90a73b9SPL ID 2c290c08-d35f-21b4-e063-6394a90a73b9SPL set ID cd387929-5b72-e3c0-e053-2a95a90adb22RxCUI 543546UNII 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. Oral, Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N472189027815 followed by a unit qualifier and the quantity

Package 72189-0278-15. 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 Jan 20, 2025.

Indications (excerpt from the label)

Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream 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 064022

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

FDA NDC Directory listings under ANDA 064022
Product	Strength	Form · route	Labeler	Product NDC
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	NuCare Pharmaceuticals,Inc.	66267-952
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	Proficient Rx LP	63187-703
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	NuCare Pharmaceuticals,Inc.	68071-2556
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	Sun Pharmaceutical Industries, Inc.	51672-1289