What is NDC 69315-504?

69315-504 is the product NDC for Nystatin, Nystatin 100000 [USP'U]/mL suspension, listed with the FDA by Leading Pharma, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Leading Pharma, LLC, NDC labeler code 69315. 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 69315-504 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-504Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0504Add 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
69315-504-47	6931505044769315050447	473 mL in 1 BOTTLE (69315-504-47)Marketed from Dec 5, 2022
69315-504-60	6931505046069315050460	1 BOTTLE in 1 PACKAGE (69315-504-60) / 60 mL in 1 BOTTLEMarketed from Dec 5, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: Leading Pharma, LLCNDC labeler code 69315
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 69315-504_eb4efca9-e5e8-4509-9437-6ad7c593a9efSPL ID eb4efca9-e5e8-4509-9437-6ad7c593a9efSPL set ID 954205d8-47ba-4c89-95cd-f0066a514cf9RxCUI 312055UNII BDF1O1C72EUPC 0369315504475
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

N469315050447 followed by a unit qualifier and the quantity

Package 69315-0504-47. 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 Nov 28, 2024.

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)

About NDC 69315-504

What is NDC 69315-504?: 69315-504 is the product NDC for Nystatin, Nystatin 100000 [USP'U]/mL suspension, listed with the FDA by Leading Pharma, LLC. 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?: Leading Pharma, LLC, NDC labeler code 69315. 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	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

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	Preferred Pharmaceuticals Inc.	68788-8561