Prescription drug · ANDA
Nystatin NDC 64950-372
Nystatin 100000 [USP'U]/mL · Suspension · Oral · Genus Lifesciences Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64950-372-06 | 6495003720664950037206 | 60 mL in 1 BOTTLE, DROPPER (64950-372-06)Marketed from May 11, 2026 | |
| 64950-372-47 | 6495003724764950037247 | 473 mL in 1 BOTTLE (64950-372-47)Marketed from Mar 24, 2026 |
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]/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Genus Lifesciences Inc.NDC labeler code 64950
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065148
- Marketing start
- Listing expires
- Other FDA classes
- Polyenes (Chemical structure)
- Identifiers
- Product ID 64950-372_319a98e0-8009-47c9-9f40-9cd288c26e48SPL ID 319a98e0-8009-47c9-9f40-9cd288c26e48SPL set ID b25cbae5-eaf5-4501-b013-02c778ca4a4eRxCUI 312055UNII BDF1O1C72EUPC 0364950372069
- 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
N464950037206followed by a unit qualifier and the quantityPackage 64950-0372-06. 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.
About NDC 64950-372
- What is NDC 64950-372?
- 64950-372 is the product NDC for Nystatin, Nystatin 100000 [USP'U]/mL suspension, listed with the FDA by Genus Lifesciences Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nystatin.
- What is the active ingredient?
- Nystatin.
- Who is the labeler?
- Genus Lifesciences Inc., NDC labeler code 64950. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nystatin?
- 77 other product NDCs are listed under this name. See all Nystatin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nystatin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-4099 | 68788-4099-01 |
| Nystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Northstar Rx LLC | 72603-491 | 72603-0491-0172603-0491-0272603-0491-03 |
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | Aurobindo Pharma Limited | 59651-907 | 59651-0907-1459651-0907-30 |
| nystatin | Nystatin 500000 [USP'U]/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-8690 | 68788-8690-01 |
| Nystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Dr. Reddy's Labratories Inc. | 75907-060 | 75907-0060-3075907-0060-4475907-0060-60 |
| Nystatin | Nystatin 100000 U/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8631 | 68788-8631-0168788-8631-03 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | American Health Packaging | 60687-800 | 60687-0800-17 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | Preferred Pharmaceuticals Inc. | 68788-8561 | 68788-8561-0468788-8561-06 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0508 | 17856-0508-0117856-0508-0317856-0508-05+1 more |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | NuCare Pharmaceuticals,Inc. | 68071-3543 | 68071-3543-06 |