Prescription drug · ANDA
Nystatin NDC 66267-952
Nystatin 100000 [USP'U]/g · Cream · Topical · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66267-952-30 | 66267095230 | 30 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
- Labeler
- NuCare Pharmaceuticals,Inc.
- 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
N466267095230followed by a unit qualifier and the quantityPackage 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.
Other NDCs under ANDA 064022
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | Proficient Rx LP | 63187-703 |
| Nystatin | Nystatin 100000 [USP'U]/g | CreamOral, Topical | DIRECT RX | 72189-278 |
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-2556 |
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-1289 |