Prescription drug · ANDA
Nystatin NDC 17856-0508
Nystatin 100000 [USP'U]/mL · Suspension · Oral · ATLANTIC BIOLOGICALS CORP.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0508-1 | 1785605080117856050801 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0508-1) / 5 mL in 1 CUP, UNIT-DOSEMarketed from Jul 15, 2024 | |
| 17856-0508-3 | 1785605080317856050803 | 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-3) / 5 mL in 1 SYRINGEMarketed from Jul 17, 2024 | |
| 17856-0508-5 | 1785605080517856050805 | 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-5) / 5 mL in 1 SYRINGEMarketed from Jul 17, 2024 | |
| 17856-0508-7 | 1785605080717856050807 | 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-7) / 1 mL in 1 SYRINGEMarketed from Jul 17, 2024 |
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
- ATLANTIC BIOLOGICALS CORP.NDC labeler code 17856
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214346
- Marketing start
- Listing expires
- Other FDA classes
- Polyenes (Chemical structure)
- Identifiers
- Product ID 17856-0508_484acdef-5f40-bd3e-e063-6394a90aebe2SPL ID 484acdef-5f40-bd3e-e063-6394a90aebe2SPL set ID 5c08148f-83e5-4f14-b0d3-af8d2c26062eRxCUI 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
N417856050801followed by a unit qualifier and the quantityPackage 17856-0508-01. 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 infections of the oral cavity caused by Candida albicans.
Excerpt only. Read the full label for complete information.
About NDC 17856-0508
- What is NDC 17856-0508?
- 17856-0508 is the product NDC for Nystatin, Nystatin 100000 [USP'U]/mL suspension, listed with the FDA by ATLANTIC BIOLOGICALS CORP.. It has 4 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?
- ATLANTIC BIOLOGICALS CORP., NDC labeler code 17856. 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 | NuCare Pharmaceuticals,Inc. | 68071-3543 | 68071-3543-06 |
Other NDCs under ANDA 214346
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 | NuCare Pharmaceuticals,Inc. | 68071-3543 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | Preferred Pharmaceuticals Inc. | 68788-8561 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | Leading Pharma, LLC | 69315-504 |