Nystatin NDC 13668-595

NDC codes

FDA NDC Directory

Product NDC (as listed)13668-595Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13668-0595Add 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
13668-595-01	13668059501	15 g in 1 TUBE (13668-595-01)Marketed from Jul 24, 2019
13668-595-02	13668059502	30 g in 1 TUBE (13668-595-02)Marketed from Jul 24, 2019

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 U/g
Dosage form: Cream
Route: Topical
Labeler: Torrent Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212557
Marketing start: Jul 24, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Polyenes (Chemical structure)
Identifiers: Product ID 13668-595_96bcc133-c446-4fce-a99a-ccd1039ded49SPL ID 96bcc133-c446-4fce-a99a-ccd1039ded49SPL set ID 559b5bd4-3564-4437-8d0a-fa3a972f8b83RxCUI 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

N413668059501 followed by a unit qualifier and the quantity

Package 13668-0595-01. 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 1, 2026.

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	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
Nystatin	Nystatin 100000 U/g	CreamTopical	A-S Medication Solutions	50090-7303