What is NDC 72189-408?

72189-408 is the product NDC for Mycostatin (nystatin), Nystatin 100000 [USP'U]/g cream, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Mycostatin?

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.

Mycostatin NDC 72189-408 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-408Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0408Add 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
72189-408-15	7218904081572189040815	15 g in 1 TUBE (72189-408-15)Marketed from Jan 5, 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): Mycostatin
Generic name (nonproprietary): nystatin
Active ingredients: Nystatin — 100000 [USP'U]/g
Dosage form: Cream
Route: Topical
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 062225
Marketing start: Jan 5, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Polyenes (Chemical structure)
Identifiers: Product ID 72189-408_4d3a9fbe-9f7f-e1a0-e063-6294a90a7857SPL ID 4d3a9fbe-9f7f-e1a0-e063-6294a90a7857SPL set ID f1857ac0-806c-4a7e-e053-2995a90abbc0UNII 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

N472189040815 followed by a unit qualifier and the quantity

Package 72189-0408-15. 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 Mar 17, 2026.

Indications (excerpt from the label)

Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Cream USP 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 72189-408

What is NDC 72189-408?: 72189-408 is the product NDC for Mycostatin (nystatin), Nystatin 100000 [USP'U]/g cream, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Mycostatin (Nystatin).
What is the active ingredient?: Nystatin.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mycostatin?: 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 062225

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

FDA NDC Directory listings under ANDA 062225
Product	Strength	Form · route	Labeler	Product NDC
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	NuCare Pharmaceuticals,Inc.	66267-953
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	Padagis Israel Pharmaceuticals Ltd	45802-059
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	Bryant Ranch Prepack	71335-2830
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	Bryant Ranch Prepack	72162-1385
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	A-S Medication Solutions	50090-2763
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	Bryant Ranch Prepack	63629-8695
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	Bryant Ranch Prepack	63629-8694
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	A-S Medication Solutions	50090-2854
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	Proficient Rx LP	63187-847
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	NuCare Pharmaceuticals,Inc.	68071-4293

Mycostatin (Nystatin) NDC 72189-408