Nystatin NDC 50090-7303

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-7303Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-7303Add 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
50090-7303-0	50090730300	15 g in 1 TUBE (50090-7303-0)Marketed from Oct 14, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 U/g
Dosage form: Cream
Route: Topical
Labeler: A-S Medication Solutions
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212557
Marketing start: Jul 24, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Polyenes (Chemical structure)
Identifiers: Product ID 50090-7303_24f18c9a-182a-4233-88bc-852c254a3d8aSPL ID 24f18c9a-182a-4233-88bc-852c254a3d8aSPL set ID 65167baa-29f8-44d3-b2d2-935c862d463eRxCUI 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450090730300 followed by a unit qualifier and the quantity

Package 50090-7303-00. 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 Oct 16, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE 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 212557

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

FDA NDC Directory listings under ANDA 212557
Product	Strength	Form · route	Labeler	Product NDC
Nystatin	Nystatin 100000 U/g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-8631
Nystatin	Nystatin 100000 U/g	CreamTopical	Torrent Pharmaceuticals Limited	13668-595
Nystatin	Nystatin 100000 U/g	CreamTopical	Bryant Ranch Prepack	72162-2576
Nystatin	Nystatin 100000 U/g	CreamTopical	Proficient Rx LP	82804-045
Nystatin	Nystatin 100000 U/g	CreamTopical	RedPharm Drug, Inc	67296-1519