Prescription drug · ANDA
Nystatin NDC 50090-1740
Nystatin 100000 [USP'U]/mL · Suspension · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1740-0 | 50090174000 | 60 mL in 1 BOTTLE, GLASS (50090-1740-0)Marketed from Mar 12, 2015 |
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 [USP'U]/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062512
- Marketing start
- Listing expires
- Other FDA classes
- Polyenes (Chemical structure)
- Identifiers
- Product ID 50090-1740_8d9b172d-a817-43b1-9cd9-24243b311f28SPL ID 8d9b172d-a817-43b1-9cd9-24243b311f28SPL set ID e069d495-7f1a-4970-8f4d-aa93d124b3fcRxCUI 312055UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090174000followed by a unit qualifier and the quantityPackage 50090-1740-00. 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 Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 062512
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 Oral Suspensionnystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | Xttrium Laboratories, Inc. | 0116-4026 |