FLUTICARE
- Product NDC
- 57483-180
- 11-digit product format
- 574830180
- Labeler code
- 57483
- Product ID
- 57483-180_38944633-aed4-4136-ab93-335d250d4e87
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- fluticasone propionate
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- INNOVUS PHARMACEUTICALS, INC.
- Application
- ANDA217088
- Marketing category
- ANDA
- Marketing start
- 2025-02-28
- Substance
- FLUTICASONE PROPIONATE
- Active strength
- 50 ug/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FLUTICARE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUTICASONE PROPIONATE | 50 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O2GMZ0LF5W |
| Rxcui | 1797907, 1996212 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57483-180-01 | FLUTICARE | 120 in 1 BOTTLE | SPRAY, METERED | 120 | | 3 |
| 57483-180-11 | FLUTICARE | 1 in 1 CARTON | SPRAY, METERED | 1 | | 3 |
| 57483-180-12 | FLUTICARE | 2 in 1 CARTON | SPRAY, METERED | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57483-180 | FLUTICARE (FLUTICASONE PROPIONATE) SPRAY, METERED [INNOVUS PHARMACEUTICALS, INC.] | 1 | Current NDC, 3 package rows | 20250305_fed545ab-6a85-4ce3-8651-370e279db49e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 57483-180-01 | 57483018001 | 120 in 1 BOTTLE | | | | | Historical |
| 57483-180-11 | 57483018011 | 1 BOTTLE in 1 CARTON (57483-180-11) / 120 SPRAY, METERED in 1 BOTTLE (57483-180-01) | 1 bottle | 2025-02-28 | No | No | Current |
| 57483-180-12 | 57483018012 | 2 BOTTLE in 1 CARTON (57483-180-12) / 120 SPRAY, METERED in 1 BOTTLE (57483-180-01) | 2 bottle | 2025-06-13 | No | No | Current |