Prescription drug · ANDA
nystatin NDC 23155-051
Nystatin 500000 [USP'U]/1 · Tablet, Coated · Oral · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-051-01 | 23155005101 | 100 TABLET, COATED in 1 BOTTLE (23155-051-01)Marketed from Oct 31, 2011 |
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 — 500000 [USP'U]/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062474
- Marketing start
- Listing expires
- Other FDA classes
- Polyenes (Chemical structure)
- Identifiers
- Product ID 23155-051_d5c4ffad-b502-4226-9ff2-8603aac88dbaSPL ID d5c4ffad-b502-4226-9ff2-8603aac88dbaSPL set ID e87b8480-987d-4f82-87bf-cf831d6984a1RxCUI 312059UNII BDF1O1C72EUPC 0323155051018
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N423155005101followed by a unit qualifier and the quantityPackage 23155-0051-01. 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 tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 062474
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 500000 [USP'U]/1 | Tablet, CoatedOral | Proficient Rx LP | 71205-575 |
| Nystatin | Nystatin 500000 [USP'U]/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-741 |
| nystatin | Nystatin 500000 [USP'U]/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 63629-8350 |
| nystatin | Nystatin 500000 [USP'U]/1 | Tablet, CoatedOral | NuCare Pharmaceuticals,Inc. | 68071-3508 |
| nystatin | Nystatin 500000 [USP'U]/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-8690 |