Prescription drug · ANDA
Nystatin NDC 72162-1385
Nystatin 100000 [USP'U]/g · Cream · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1385-2 | 7216213850272162138502 | 1 TUBE in 1 CARTON (72162-1385-2) / 15 g in 1 TUBEMarketed from Apr 2, 2025 | |
| 72162-1385-3 | 7216213850372162138503 | 1 TUBE in 1 CARTON (72162-1385-3) / 30 g in 1 TUBEMarketed from Apr 2, 2025 |
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]/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Bryant Ranch PrepackNDC labeler code 72162
- 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 72162-1385_ea5d13f8-38cd-4010-a78f-ccafe2002c4aSPL ID ea5d13f8-38cd-4010-a78f-ccafe2002c4aSPL set ID cc8f9a06-cd1b-40e9-bc22-7e19f6d89b83RxCUI 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
N472162138502followed by a unit qualifier and the quantityPackage 72162-1385-02. 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 72162-1385
- What is NDC 72162-1385?
- 72162-1385 is the product NDC for Nystatin, Nystatin 100000 [USP'U]/g cream, listed with the FDA by Bryant Ranch Prepack. 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?
- Bryant Ranch Prepack, NDC labeler code 72162. 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 | Padagis Israel Pharmaceuticals Ltd | 45802-059 |
| 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 | 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 |