NDC codes

FDA NDC Directory
Product NDC (as listed)21922-031Labeler and product segments. Claims need a package NDC.
Product NDC at billing width21922-0031Add 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 NDC11-digit (billing)PackageCopy
21922-031-0421922003104219220031041 TUBE in 1 CARTON (21922-031-04) / 15 g in 1 TUBEMarketed from Sep 28, 2019
21922-031-0521922003105219220031051 TUBE in 1 CARTON (21922-031-05) / 30 g in 1 TUBEMarketed from Sep 28, 2019
21922-031-0721922003107219220031071 TUBE in 1 CARTON (21922-031-07) / 60 g in 1 TUBEMarketed from Sep 28, 2019

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
Encube Ethicals, Inc.NDC labeler code 21922
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207741
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)Polyenes (Chemical structure)
Identifiers
Product ID 21922-031_b18e996f-bdb8-4028-9862-fbab75aebf69SPL ID b18e996f-bdb8-4028-9862-fbab75aebf69SPL set ID d33829fc-86df-4e28-82c3-9dbcd8a9e28dRxCUI 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

N421922003104 followed by a unit qualifier and the quantity

Package 21922-0031-04. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE Nystatin and Triamcinolone Acetonide Ointment, 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)

About NDC 21922-031

What is NDC 21922-031?
21922-031 is the product NDC for Nystatin and Triamcinolone Acetonide, Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g ointment, listed with the FDA by Encube Ethicals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nystatin and Triamcinolone Acetonide.
What is the active ingredient?
Nystatin, Triamcinolone acetonide.
Who is the labeler?
Encube Ethicals, Inc., NDC labeler code 21922. 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 and Triamcinolone Acetonide?
34 other product NDCs are listed under this name. See all Nystatin and Triamcinolone Acetonide 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 and Triamcinolone Acetonide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nystatin and Triamcinolone AcetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gCreamTopicalAlembic Pharmaceuticals Limited46708-60646708-0606-1546708-0606-3046708-0606-60
Nystatin and Triamcinolone AcetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gCreamTopicalPreferred Pharmaceuticals Inc.68788-880868788-8808-03
Nystatin and triamcinolone acetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gCreamTopicalPreferred Pharmaceuticals Inc.68788-866268788-8662-03
Nystatin and triamcinolone acetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gCreamTopicalNuCare Pharmaceuticals, Inc.68071-397268071-3972-03
Nystatin and triamcinolone acetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gCreamTopicalMacleods Pharmaceuticals Limited33342-48233342-0482-1533342-0482-3033342-0482-60
Nystatin and Triamcinolone AcetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gCreamTopicalPreferred Pharmaceuticals Inc., USA68788-824568788-8245-03
Nystatin and Triamcinolone AcetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gOintmentTopicalAlembic Pharmaceuticals Inc.62332-58562332-0585-1562332-0585-3062332-0585-60
Nystatin and triamcinolone acetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gOintmentTopicalMacleods Pharmaceuticals Limited33342-48333342-0483-1533342-0483-3033342-0483-60
Nystatin and Triamcinolone AcetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gCreamTopicalAlembic Pharmaceuticals Inc.62332-60662332-0606-1562332-0606-3062332-0606-60
Nystatin and Triamcinolone AcetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gCreamTopicalTorrent Pharmaceuticals Limited13668-61013668-0610-0113668-0610-0213668-0610-05

All 35 Nystatin and Triamcinolone Acetonide NDCs

Other NDCs under ANDA 207741

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

FDA NDC Directory listings under ANDA 207741
ProductStrengthForm · routeLabelerProduct NDC
Nystatin and Triamcinolone AcetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gOintmentTopicalBryant Ranch Prepack72162-1275
Nystatin and Triamcinolone AcetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gOintmentTopicalBryant Ranch Prepack71335-2847
Nystatin and Triamcinolone AcetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gOintmentTopicalBryant Ranch Prepack71335-2857
Nystatin and Triamcinolone AcetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gOintmentTopicalBryant Ranch Prepack63629-2495
Nystatin and Triamcinolone AcetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gOintmentTopicalBryant Ranch Prepack63629-2496
Nystatin and Triamcinolone AcetonideNystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/gOintmentTopicalBryant Ranch Prepack63629-2497

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