Prescription drug · ANDA
Nystatin And Triamcinolone Acetonide (Nystatin, triamcinolone acetonide) NDC 45802-880
Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g · Cream · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-880-14 | 4580208801445802088014 | 1 TUBE in 1 CARTON (45802-880-14) / 15 g in 1 TUBEMarketed from Nov 27, 2017 | |
| 45802-880-94 | 4580208809445802088094 | 1 TUBE in 1 CARTON (45802-880-94) / 30 g in 1 TUBEMarketed from Nov 27, 2017 | |
| 45802-880-96 | 4580208809645802088096 | 1 TUBE in 1 CARTON (45802-880-96) / 60 g in 1 TUBEMarketed from Nov 27, 2017 |
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 And Triamcinolone Acetonide
- Generic name (nonproprietary)
- nystatin, triamcinolone acetonide
- Active ingredients
- Nystatin — 100000 [USP'U]/gTriamcinolone acetonide — 1 mg/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 208479
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Polyenes (Chemical structure)
- Identifiers
- Product ID 45802-880_3f4fba52-76cc-4ac5-aee1-e562d5c37a64SPL ID 3f4fba52-76cc-4ac5-aee1-e562d5c37a64SPL set ID 92fc188d-4f3e-4d18-aaf1-c9e76b12b75bRxCUI 1053753UNII BDF1O1C72E, F446C597KA
- Pharmacologic class
- Corticosteroid; 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
N445802088014followed by a unit qualifier and the quantityPackage 45802-0880-14. 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 and Triamcinolone Acetonide Cream is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
Excerpt only. Read the full label for complete information.
About NDC 45802-880
- What is NDC 45802-880?
- 45802-880 is the product NDC for Nystatin And Triamcinolone Acetonide, Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g cream, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nystatin And Triamcinolone Acetonide (Nystatin, triamcinolone acetonide).
- What is the active ingredient?
- Nystatin, Triamcinolone acetonide.
- 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 And Triamcinolone Acetonide?
- 34 other product NDCs are listed under this name. See all Nystatin And Triamcinolone Acetonide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nystatin And Triamcinolone Acetonide 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 and Triamcinolone Acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | CreamTopical | Alembic Pharmaceuticals Limited | 46708-606 | 46708-0606-1546708-0606-3046708-0606-60 |
| Nystatin and Triamcinolone Acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8808 | 68788-8808-03 |
| Nystatin and triamcinolone acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8662 | 68788-8662-03 |
| Nystatin and triamcinolone acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | CreamTopical | NuCare Pharmaceuticals, Inc. | 68071-3972 | 68071-3972-03 |
| Nystatin and triamcinolone acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | CreamTopical | Macleods Pharmaceuticals Limited | 33342-482 | 33342-0482-1533342-0482-3033342-0482-60 |
| Nystatin and Triamcinolone Acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | CreamTopical | Preferred Pharmaceuticals Inc., USA | 68788-8245 | 68788-8245-03 |
| Nystatin and Triamcinolone Acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | OintmentTopical | Alembic Pharmaceuticals Inc. | 62332-585 | 62332-0585-1562332-0585-3062332-0585-60 |
| Nystatin and triamcinolone acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | OintmentTopical | Macleods Pharmaceuticals Limited | 33342-483 | 33342-0483-1533342-0483-3033342-0483-60 |
| Nystatin and Triamcinolone Acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | CreamTopical | Alembic Pharmaceuticals Inc. | 62332-606 | 62332-0606-1562332-0606-3062332-0606-60 |
| Nystatin and Triamcinolone Acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | CreamTopical | Torrent Pharmaceuticals Limited | 13668-610 | 13668-0610-0113668-0610-0213668-0610-05 |
Other NDCs under ANDA 208479
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 And Triamcinolone Acetonidenystatin, triamcinolone acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8688 |
| Nystatin And Triamcinolone Acetonidenystatin, triamcinolone acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8689 |
| Nystatin And Triamcinolone Acetonidenystatin, triamcinolone acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8690 |
| Nystatin And Triamcinolone Acetonidenystatin, triamcinolone acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-2491 |
| Nystatin And Triamcinolone Acetonidenystatin, triamcinolone acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | CreamTopical | Bryant Ranch Prepack | 71335-2894 |
| Nystatin And Triamcinolone Acetonidenystatin, triamcinolone acetonide | Nystatin 100000 [USP'U]/g; Triamcinolone acetonide 1 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-1433 |