nystatin NDC 68788-8690

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8690Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8690Add 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
68788-8690-1	68788869001	120 TABLET, COATED in 1 BOTTLE (68788-8690-1)Marketed from Jun 7, 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 — 500000 [USP'U]/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Preferred Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 062474
Marketing start: Jun 7, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Polyenes (Chemical structure)
Identifiers: Product ID 68788-8690_a9d91711-f249-4f9e-b3cc-17ad5371d4d5SPL ID a9d91711-f249-4f9e-b3cc-17ad5371d4d5SPL set ID 197e3046-3e58-4246-b260-f3995dce41a1RxCUI 312059UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468788869001 followed by a unit qualifier and the quantity

Package 68788-8690-01. 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 Aug 5, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Nystatin tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 062474

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

FDA NDC Directory listings under ANDA 062474
Product	Strength	Form · route	Labeler	Product NDC
nystatin	Nystatin 500000 [USP'U]/1	Tablet, CoatedOral	Proficient Rx LP	71205-575
Nystatin	Nystatin 500000 [USP'U]/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-741
nystatin	Nystatin 500000 [USP'U]/1	Tablet, CoatedOral	Bryant Ranch Prepack	63629-8350
nystatin	Nystatin 500000 [USP'U]/1	Tablet, CoatedOral	NuCare Pharmaceuticals,Inc.	68071-3508
nystatin	Nystatin 500000 [USP'U]/1	Tablet, CoatedOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-051