What is NDC 0116-4026?

0116-4026 is the product NDC for Nystatin Oral Suspension (nystatin), Nystatin 100000 [USP'U]/mL suspension, listed with the FDA by Xttrium Laboratories, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Nystatin Oral Suspension (Nystatin).

Xttrium Laboratories, Inc., NDC labeler code 0116. 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 Oral Suspension?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nystatin Oral Suspension NDC 0116-4026

NDC codes

FDA NDC Directory

Product NDC (as listed)0116-4026Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00116-4026Add 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
0116-4026-11	0011640261100116402611	10 TRAY in 1 CASE (0116-4026-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05)Marketed from Feb 6, 2026
0116-4026-16	0011640261600116402616	473 mL in 1 BOTTLE, PLASTIC (0116-4026-16)Marketed from Feb 9, 2026
0116-4026-50	0011640265000116402650	5 TRAY in 1 CASE (0116-4026-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05)Marketed from Feb 9, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Oral Suspension
Generic name (nonproprietary): nystatin
Active ingredients: Nystatin — 100000 [USP'U]/mL
Dosage form: Suspension
Route: Oral
Labeler: Xttrium Laboratories, Inc.NDC labeler code 0116
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 062512
Marketing start: Feb 6, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Polyenes (Chemical structure)
Identifiers: Product ID 0116-4026_4a2ff89a-52fe-8bf9-e063-6394a90a7f1dSPL ID 4a2ff89a-52fe-8bf9-e063-6394a90a7f1dSPL set ID 4a670371-d373-1ba6-e063-6394a90a13b6RxCUI 312055UNII 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

N400116402611 followed by a unit qualifier and the quantity

Package 00116-4026-11. 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 Feb 6, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0116-4026

What is NDC 0116-4026?: 0116-4026 is the product NDC for Nystatin Oral Suspension (nystatin), Nystatin 100000 [USP'U]/mL suspension, listed with the FDA by Xttrium Laboratories, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nystatin Oral Suspension (Nystatin).
What is the active ingredient?: Nystatin.
Who is the labeler?: Xttrium Laboratories, Inc., NDC labeler code 0116. 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 Oral Suspension?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 062512

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

FDA NDC Directory listings under ANDA 062512
Product	Strength	Form · route	Labeler	Product NDC
Nystatin	Nystatin 100000 [USP'U]/mL	SuspensionOral	A-S Medication Solutions	50090-1740

Nystatin Oral Suspension (Nystatin) NDC 0116-4026