What is NDC 68462-314?

68462-314 is the product NDC for Nystatin and Triamcinolone Acetonide, Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g cream, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Nystatin, Triamcinolone acetonide.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nystatin and Triamcinolone Acetonide NDC 68462-314

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-314Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0314Add 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
68462-314-17	6846203141768462031417	1 TUBE in 1 CARTON (68462-314-17) / 15 g in 1 TUBEMarketed from Oct 25, 2016
68462-314-35	6846203143568462031435	1 TUBE in 1 CARTON (68462-314-35) / 30 g in 1 TUBEMarketed from Oct 25, 2016
68462-314-65	6846203146568462031465	1 TUBE in 1 CARTON (68462-314-65) / 60 g in 1 TUBEMarketed from Oct 25, 2016

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: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208136
Marketing start: Oct 24, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)Polyenes (Chemical structure)
Identifiers: Product ID 68462-314_39b52cdc-3387-4aac-9a01-e4c6ae68f282SPL ID 39b52cdc-3387-4aac-9a01-e4c6ae68f282SPL set ID 44a37f35-e533-4b09-bbcf-97ffaff1920bRxCUI 1053753UNII 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

N468462031417 followed by a unit qualifier and the quantity

Package 68462-0314-17. 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 Jan 31, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE Nystatin and triamcinolone acetonide cream 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 68462-314

What is NDC 68462-314?: 68462-314 is the product NDC for Nystatin and Triamcinolone Acetonide, Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g cream, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nystatin and Triamcinolone Acetonide	Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g	CreamTopical	Alembic Pharmaceuticals Limited	46708-606	46708-0606-1546708-0606-3046708-0606-60
Nystatin and Triamcinolone Acetonide	Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-8808	68788-8808-03
Nystatin and triamcinolone acetonide	Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-8662	68788-8662-03
Nystatin and triamcinolone acetonide	Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g	CreamTopical	NuCare Pharmaceuticals, Inc.	68071-3972	68071-3972-03
Nystatin and triamcinolone acetonide	Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g	CreamTopical	Macleods Pharmaceuticals Limited	33342-482	33342-0482-1533342-0482-3033342-0482-60
Nystatin and Triamcinolone Acetonide	Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g	CreamTopical	Preferred Pharmaceuticals Inc., USA	68788-8245	68788-8245-03
Nystatin and Triamcinolone Acetonide	Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g	OintmentTopical	Alembic Pharmaceuticals Inc.	62332-585	62332-0585-1562332-0585-3062332-0585-60
Nystatin and triamcinolone acetonide	Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g	OintmentTopical	Macleods Pharmaceuticals Limited	33342-483	33342-0483-1533342-0483-3033342-0483-60
Nystatin and Triamcinolone Acetonide	Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g	CreamTopical	Alembic Pharmaceuticals Inc.	62332-606	62332-0606-1562332-0606-3062332-0606-60
Nystatin and Triamcinolone Acetonide	Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g	CreamTopical	Torrent Pharmaceuticals Limited	13668-610	13668-0610-0113668-0610-0213668-0610-05

All 35 Nystatin and Triamcinolone Acetonide NDCs

Other NDCs under ANDA 208136

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

FDA NDC Directory listings under ANDA 208136
Product	Strength	Form · route	Labeler	Product NDC
Nystatin and Triamcinolone Acetonide	Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g	CreamTopical	Preferred Pharmaceuticals Inc., USA	68788-8245