Nystatin NDC 63629-2516

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-2516Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-2516Add 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
63629-2516-1	63629251601	15 g in 1 TUBE (63629-2516-1)Marketed from May 18, 2021

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: Ointment
Route: Topical
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207767
Marketing start: Jun 24, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Polyenes (Chemical structure)
Identifiers: Product ID 63629-2516_76c4c131-29b4-4e9a-af1b-ca97c467e221SPL ID 76c4c131-29b4-4e9a-af1b-ca97c467e221SPL set ID 53d1c23b-9cf2-4941-8701-8a7da1b066ccRxCUI 884308UNII 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

N463629251601 followed by a unit qualifier and the quantity

Package 63629-2516-01. 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 Mar 3, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Nystatin Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Ointment 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 207767

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

FDA NDC Directory listings under ANDA 207767
Product	Strength	Form · route	Labeler	Product NDC
Nystatin	Nystatin 100000 U/g	OintmentTopical	A-S Medication Solutions	50090-5845
Nystatin	Nystatin 100000 U/g	OintmentTopical	Bryant Ranch Prepack	63629-2515
Nystatin	Nystatin 100000 U/g	OintmentTopical	Viona Pharmaceuticals Inc	72578-089
Nystatin	Nystatin 100000 U/g	OintmentTopical	Zydus Lifesciences Limited	70771-1357
Nystatin	Nystatin 100000 U/g	OintmentTopical	Bryant Ranch Prepack	72162-2007