Prescription drug · ANDA
Nystatin NDC 50090-5845
Nystatin 100000 U/g · Ointment · Topical · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5845-0 | 50090584500 | 15 g in 1 TUBE (50090-5845-0)Marketed from Nov 4, 2021 |
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
- Ointment
- Route
- Topical
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207767
- Marketing start
- Listing expires
- Other FDA classes
- Polyenes (Chemical structure)
- Identifiers
- Product ID 50090-5845_b497547b-3c93-4ea2-bc0e-5f0b1397b831SPL ID b497547b-3c93-4ea2-bc0e-5f0b1397b831SPL set ID 6a3bb3da-adf9-46d2-a5ff-f796e7aae7a1RxCUI 884308UNII 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
N450090584500followed by a unit qualifier and the quantityPackage 50090-5845-00. 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 Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207767
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 | OintmentTopical | Bryant Ranch Prepack | 63629-2515 |
| Nystatin | Nystatin 100000 U/g | OintmentTopical | Bryant Ranch Prepack | 63629-2516 |
| Nystatin | Nystatin 100000 U/g | OintmentTopical | Viona Pharmaceuticals Inc | 72578-089 |
| Nystatin | Nystatin 100000 U/g | OintmentTopical | Zydus Lifesciences Limited | 70771-1357 |
| Nystatin | Nystatin 100000 U/g | OintmentTopical | Bryant Ranch Prepack | 72162-2007 |