nystatin and triamcinolone acetonide NDC 45802-244

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-244Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0244Add 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
45802-244-14	45802024414	1 TUBE in 1 CARTON (45802-244-14) / 15 g in 1 TUBEMarketed from Oct 18, 2017
45802-244-94	45802024494	1 TUBE in 1 CARTON (45802-244-94) / 30 g in 1 TUBEMarketed from Oct 18, 2017
45802-244-96	45802024496	1 TUBE in 1 CARTON (45802-244-96) / 60 g in 1 TUBEMarketed from Oct 18, 2017

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 and triamcinolone acetonide
Generic name (nonproprietary): nystatin and triamcinolone acetonide
Active ingredients: Nystatin — 100000 [USP'U]/gTriamcinolone acetonide — 1 mg/g
Dosage form: Ointment
Route: Topical
Labeler: Padagis Israel Pharmaceuticals Ltd
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207380
Marketing start: Oct 18, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)Polyenes (Chemical structure)
Identifiers: Product ID 45802-244_5797c2ea-37cd-4a6f-87ce-030df00cb949SPL ID 5797c2ea-37cd-4a6f-87ce-030df00cb949SPL set ID 605540d8-7189-49b9-9e91-572f6b519faeRxCUI 1053697UNII BDF1O1C72E, F446C597KA
Pharmacologic class: Corticosteroid; 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

N445802024414 followed by a unit qualifier and the quantity

Package 45802-0244-14. 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 Mar 1, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Nystatin and Triamcinolone Acetonide Ointment is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207380

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

FDA NDC Directory listings under ANDA 207380
Product	Strength	Form · route	Labeler	Product NDC
nystatin and triamcinolone acetonide	Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g	OintmentTopical	Bryant Ranch Prepack	72162-1403