Nystatin NDC 68788-8631

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8631Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8631Add 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
68788-8631-1	68788863101	15 g in 1 TUBE (68788-8631-1)Marketed from Apr 15, 2024
68788-8631-3	68788863103	30 g in 1 TUBE (68788-8631-3)Marketed from Apr 15, 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 — 100000 U/g
Dosage form: Cream
Route: Topical
Labeler: Preferred Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212557
Marketing start: Apr 15, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Polyenes (Chemical structure)
Identifiers: Product ID 68788-8631_6481ba58-8416-4c9f-90b1-4e4507dee519SPL ID 6481ba58-8416-4c9f-90b1-4e4507dee519SPL set ID d92f67a7-dcae-41c0-9a35-dbafa2361170RxCUI 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

N468788863101 followed by a unit qualifier and the quantity

Package 68788-8631-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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	Torrent Pharmaceuticals Limited	13668-595
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