Prescription drug · ANDA
Nystatin NDC 72162-2576
Nystatin 100000 U/g · Cream · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2576-2 | 72162257602 | 15 g in 1 TUBE (72162-2576-2)Marketed from Nov 17, 2025 | |
| 72162-2576-3 | 72162257603 | 30 g in 1 TUBE (72162-2576-3)Marketed from Nov 17, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 U/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212557
- Marketing start
- Listing expires
- Other FDA classes
- Polyenes (Chemical structure)
- Identifiers
- Product ID 72162-2576_6467595c-fcd2-4dd8-8521-a12d9980ce27SPL ID 6467595c-fcd2-4dd8-8521-a12d9980ce27SPL set ID 2d2c4f79-95b5-417e-b5c1-8fac1dd09ddcRxCUI 543546UNII BDF1O1C72E
- 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
N472162257602followed by a unit qualifier and the quantityPackage 72162-2576-02. 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 212557
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 U/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8631 |
| Nystatin | Nystatin 100000 U/g | CreamTopical | Torrent Pharmaceuticals Limited | 13668-595 |
| Nystatin | Nystatin 100000 U/g | CreamTopical | Proficient Rx LP | 82804-045 |
| Nystatin | Nystatin 100000 U/g | CreamTopical | RedPharm Drug, Inc | 67296-1519 |
| Nystatin | Nystatin 100000 U/g | CreamTopical | A-S Medication Solutions | 50090-7303 |