Prescription drug · ANDA
Nystatin NDC 85742-013
Nystatin 100000 U/mL · Suspension · Oral · Kanchan Healthcare Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85742-013-10 | 8574200131085742001310 | 1 BOTTLE in 1 CARTON (85742-013-10) / 60 mL in 1 BOTTLEMarketed from Sep 12, 2025 | |
| 85742-013-11 | 8574200131185742001311 | 473 mL in 1 BOTTLE (85742-013-11)Marketed from Sep 12, 2025 |
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 U/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Kanchan Healthcare IncNDC labeler code 85742
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062832
- Marketing start
- Listing expires
- Other FDA classes
- Polyenes (Chemical structure)
- Identifiers
- Product ID 85742-013_8e20e512-dc60-4315-89d6-b76f19398856SPL ID 8e20e512-dc60-4315-89d6-b76f19398856
- 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
N485742001310followed by a unit qualifier and the quantityPackage 85742-0013-10. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 85742-013
- What is NDC 85742-013?
- 85742-013 is the product NDC for Nystatin, Nystatin 100000 U/mL suspension, listed with the FDA by Kanchan Healthcare 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?
- Kanchan Healthcare Inc, NDC labeler code 85742. 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]/mL | SuspensionOral | Genus Lifesciences Inc. | 64950-372 | 64950-0372-0664950-0372-47 |
| 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 |
Other NDCs under ANDA 062832
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 [USP'U]/mL | SuspensionOral | Bryant Ranch Prepack | 63629-8520 |
| Nystatin | Nystatin 100000 U/mL | SuspensionOral | Bryant Ranch Prepack | 72162-2645 |
| Nystatin | Nystatin 100000 U/mL | SuspensionOral | Kesin Pharma Corporation | 81033-015 |