Prescription drug · ANDA
Nystatin NDC 45802-059
Nystatin 100000 [USP'U]/g · Cream · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-059-11 | 4580200591145802005911 | 1 TUBE in 1 CARTON (45802-059-11) / 30 g in 1 TUBEMarketed from Sep 21, 2006 | |
| 45802-059-35 | 4580200593545802005935 | 1 TUBE in 1 CARTON (45802-059-35) / 15 g in 1 TUBEMarketed from Jan 25, 2007 |
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]/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062225
- Marketing start
- Listing expires
- Other FDA classes
- Polyenes (Chemical structure)
- Identifiers
- Product ID 45802-059_e2839c50-5b8f-4e7b-9636-d22687038a89SPL ID e2839c50-5b8f-4e7b-9636-d22687038a89SPL set ID e630aa3d-11a6-4300-942a-cbdf2d016f77RxCUI 543546UNII 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
N445802005911followed by a unit qualifier and the quantityPackage 45802-0059-11. 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 Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Cream USP is not indicated for systemic, oral, intravaginal or ophthalmic use.
Excerpt only. Read the full label for complete information.
About NDC 45802-059
- What is NDC 45802-059?
- 45802-059 is the product NDC for Nystatin, Nystatin 100000 [USP'U]/g cream, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. 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?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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 062225
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]/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 66267-953 |
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | Bryant Ranch Prepack | 71335-2830 |
| Mycostatinnystatin | Nystatin 100000 [USP'U]/g | CreamTopical | Direct_Rx | 72189-408 |
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | Bryant Ranch Prepack | 72162-1385 |
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | A-S Medication Solutions | 50090-2763 |
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | Bryant Ranch Prepack | 63629-8695 |
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | Bryant Ranch Prepack | 63629-8694 |
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | A-S Medication Solutions | 50090-2854 |
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | Proficient Rx LP | 63187-847 |
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-4293 |