Over-the-counter drug · ANDA
Fluticare (fluticasone propionate) NDC 57483-180
Fluticasone propionate 50 ug/1 · Spray, Metered · Nasal · INNOVUS PHARMACEUTICALS, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57483-180-11 | 57483018011 | 1 BOTTLE in 1 CARTON (57483-180-11) / 120 SPRAY, METERED in 1 BOTTLE (57483-180-01)Marketed from Feb 28, 2025 | |
| 57483-180-12 | 57483018012 | 2 BOTTLE in 1 CARTON (57483-180-12) / 120 SPRAY, METERED in 1 BOTTLE (57483-180-01)Marketed from Jun 13, 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)
- Fluticare
- Generic name (nonproprietary)
- fluticasone propionate
- Active ingredients
- Fluticasone propionate — 50 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217088
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 57483-180_38944633-aed4-4136-ab93-335d250d4e87SPL ID 38944633-aed4-4136-ab93-335d250d4e87SPL set ID fed545ab-6a85-4ce3-8651-370e279db49eRxCUI 1797907, 1996212UNII O2GMZ0LF5W
- Pharmacologic class
- Corticosteroid
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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N457483018011followed by a unit qualifier and the quantityPackage 57483-0180-11. 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)
Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion itchy, watery eyes itchy nose runny nose sneezing
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217088
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 |
|---|---|---|---|---|
| Mucinex Nasal Congestion and Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Reckitt Benckiser LLC | 72854-227 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Aurohealth LLC | 58602-017 |
| Childrens Fluticasone Propionatefluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Aurohealth LLC | 58602-018 |
| 365 Whole Foods Market Fluticasone Propionatefluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Whole Foods Market, Inc. | 42681-0058 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Family Dollar Stores, LLC | 55319-058 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | YYBA Corp | 73581-510 |