NDC codes

FDA NDC Directory
Product NDC (as listed)66267-952Labeler and product segments. Claims need a package NDC.
Product NDC at billing width66267-0952Add 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
66267-952-306626709523030 g in 1 BOX (66267-952-30)Marketed from Aug 24, 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
Generic name (nonproprietary)
nystatin
Active ingredients
Nystatin — 100000 [USP'U]/g
Dosage form
Cream
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 064022
Marketing start
Listing expires
Other FDA classes
Polyenes (Chemical structure)
Identifiers
Product ID 66267-952_1fa7bc90-f394-592a-e063-6394a90acab9SPL ID 1fa7bc90-f394-592a-e063-6394a90acab9SPL set ID 57825c04-dcb5-b76d-e053-2991aa0a4c1dRxCUI 543546UNII BDF1O1C72EUPC 0366267952309
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N466267095230 followed by a unit qualifier and the quantity

Package 66267-0952-30. 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 cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 064022

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

FDA NDC Directory listings under ANDA 064022
ProductStrengthForm · routeLabelerProduct NDC
NystatinNystatin 100000 [USP'U]/gCreamTopicalProficient Rx LP63187-703
NystatinNystatin 100000 [USP'U]/gCreamOral, TopicalDIRECT RX72189-278
NystatinNystatin 100000 [USP'U]/gCreamTopicalNuCare Pharmaceuticals,Inc.68071-2556
NystatinNystatin 100000 [USP'U]/gCreamTopicalSun Pharmaceutical Industries, Inc.51672-1289

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