Nystatin and triamcinolone acetonide NDC 33342-482

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-482Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0482Add 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
33342-482-15	33342048215	1 TUBE in 1 CARTON (33342-482-15) / 15 g in 1 TUBEMarketed from Aug 31, 2022
33342-482-30	33342048230	1 TUBE in 1 CARTON (33342-482-30) / 30 g in 1 TUBEMarketed from Aug 31, 2022
33342-482-60	33342048260	1 TUBE in 1 CARTON (33342-482-60) / 60 g in 1 TUBEMarketed from Aug 31, 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 and triamcinolone acetonide
Generic name (nonproprietary): nystatin and triamcinolone acetonide
Active ingredients: Nystatin — 100000 [USP'U]/gTriamcinolone acetonide — 1 mg/g
Dosage form: Cream
Route: Topical
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214181
Marketing start: Aug 31, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)Polyenes (Chemical structure)
Identifiers: Product ID 33342-482_f23f4207-1d1b-4eb2-9b7f-a70ced65192aSPL ID f23f4207-1d1b-4eb2-9b7f-a70ced65192aSPL set ID 57c4ebe8-7a8d-4fc0-b6cf-a276b68327fbRxCUI 1053753UNII BDF1O1C72E, F446C597KAUPC 0333342482303, 0333342482150
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

N433342048215 followed by a unit qualifier and the quantity

Package 33342-0482-15. 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 Sep 7, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Nystatin and triamcinolone acetonide cream, USP 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 214181

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

FDA NDC Directory listings under ANDA 214181
Product	Strength	Form · route	Labeler	Product NDC
Nystatin and triamcinolone acetonide	Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g	CreamTopical	NuCare Pharmaceuticals, Inc.	68071-3972
Nystatin and triamcinolone acetonide	Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-8662