Fluticasone Propionate
- Product NDC
- 55681-389
- 11-digit product format
- 556810389
- Labeler code
- 55681
- Product ID
- 55681-389_35b785eb-acff-cbf4-e063-6294a90a8a60
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fluticasone Propionate
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- TWIN MED LLC
- Application
- ANDA208150
- Marketing category
- ANDA
- Marketing start
- 2025-05-01
- 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
- Fluticasone Propionate
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55681-389-14 | Fluticasone Propionate | 1 in 1 CARTON | SPRAY, METERED | 1 | | 1 |
| 55681-389-14 | Fluticasone Propionate | 144 in 1 BOTTLE, SPRAY | SPRAY, METERED | 144 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55681-389 | FLUTICASONE PROPIONATE SPRAY, METERED [TWIN MED LLC] | 1 | Current NDC, 2 package rows | 20250523_9337aa4b-382d-4ab9-b312-60417cdd40cf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55681-389-14 | 55681038914 | 1 BOTTLE, SPRAY in 1 CARTON (55681-389-14) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY | 2025-05-01 | No | No | Historical |