What is NDC 68788-8561?

68788-8561 is the product NDC for Nystatin, Nystatin 100000 [USP'U]/mL suspension, 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 68788-8561 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8561Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8561Add 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
68788-8561-4	6878885610468788856104	473 mL in 1 BOTTLE (68788-8561-4)Marketed from Jan 8, 2024
68788-8561-6	6878885610668788856106	60 mL in 1 BOTTLE (68788-8561-6)Marketed from Jan 8, 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 [USP'U]/mL
Dosage form: Suspension
Route: Oral
Labeler: Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214346
Marketing start: Jan 8, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Polyenes (Chemical structure)
Identifiers: Product ID 68788-8561_bf047ee0-bcba-42cf-b968-aa5088eff729SPL ID bf047ee0-bcba-42cf-b968-aa5088eff729
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

N468788856104 followed by a unit qualifier and the quantity

Package 68788-8561-04. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 68788-8561

What is NDC 68788-8561?: 68788-8561 is the product NDC for Nystatin, Nystatin 100000 [USP'U]/mL suspension, 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 U/g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-8631	68788-8631-0168788-8631-03
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	American Health Packaging	60687-800	60687-0800-17
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 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	NuCare Pharmaceuticals,Inc.	68071-3543
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	Leading Pharma, LLC	69315-504