What is NDC 68788-8631?

68788-8631 is the product NDC for Nystatin, Nystatin 100000 U/g cream, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nystatin?

77 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nystatin NDC 68788-8631 | National Drug Code

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	6878886310168788863101	15 g in 1 TUBE (68788-8631-1)Marketed from Apr 15, 2024
68788-8631-3	6878886310368788863103	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.NDC labeler code 68788
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

Current FDA label (SPL), effective Aug 4, 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)

About NDC 68788-8631

What is NDC 68788-8631?: 68788-8631 is the product NDC for Nystatin, Nystatin 100000 U/g cream, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nystatin.
What is the active ingredient?: Nystatin.
Who is the labeler?: Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nystatin?: 77 other product NDCs are listed under this name. See all Nystatin NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nystatin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-4099	68788-4099-01
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	Genus Lifesciences Inc.	64950-372	64950-0372-0664950-0372-47
Nystatin	Nystatin 100000 [USP'U]/g	PowderTopical	Northstar Rx LLC	72603-491	72603-0491-0172603-0491-0272603-0491-03
Nystatin	Nystatin 100000 [USP'U]/g	CreamTopical	Aurobindo Pharma Limited	59651-907	59651-0907-1459651-0907-30
nystatin	Nystatin 500000 [USP'U]/1	Tablet, CoatedOral	Preferred Pharmaceuticals Inc.	68788-8690	68788-8690-01
Nystatin	Nystatin 100000 [USP'U]/g	PowderTopical	Dr. Reddy's Labratories Inc.	75907-060	75907-0060-3075907-0060-4475907-0060-60
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	American Health Packaging	60687-800	60687-0800-17
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	Preferred Pharmaceuticals Inc.	68788-8561	68788-8561-0468788-8561-06
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	ATLANTIC BIOLOGICALS CORP.	17856-0508	17856-0508-0117856-0508-0317856-0508-05+1 more
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	NuCare Pharmaceuticals,Inc.	68071-3543	68071-3543-06

All 78 Nystatin NDCs

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	A-S Medication Solutions	50090-7303
Nystatin	Nystatin 100000 U/g	CreamTopical	RedPharm Drug, Inc	67296-1519
Nystatin	Nystatin 100000 U/g	CreamTopical	Bryant Ranch Prepack	72162-2576
Nystatin	Nystatin 100000 U/g	CreamTopical	Proficient Rx LP	82804-045