Nystatin NDC 68071-3543

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3543Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3543Add 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
68071-3543-6	68071354306	1 BOTTLE in 1 PACKAGE (68071-3543-6) / 60 mL in 1 BOTTLEMarketed from Nov 29, 2023

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 [USP'U]/mL
Dosage form: Suspension
Route: Oral
Labeler: NuCare Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214346
Marketing start: Dec 5, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Polyenes (Chemical structure)
Identifiers: Product ID 68071-3543_2ad1d4c2-cbc9-0304-e063-6394a90aae6eSPL ID 2ad1d4c2-cbc9-0304-e063-6394a90aae6eSPL set ID 0b4dfd5e-641e-40e9-e063-6294a90a3fdaRxCUI 312055UNII BDF1O1C72EUPC 0368071354362
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 products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468071354306 followed by a unit qualifier and the quantity

Package 68071-3543-06. 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 3, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214346

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

FDA NDC Directory listings under ANDA 214346
Product	Strength	Form · route	Labeler	Product NDC
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	ATLANTIC BIOLOGICALS CORP.	17856-0508
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	Preferred Pharmaceuticals Inc.	68788-8561
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	Leading Pharma, LLC	69315-504