Fluticasone Propionate
- Product NDC
- 68196-503
- 11-digit product format
- 681960503
- Labeler code
- 68196
- Product ID
- 68196-503_f44d1db6-7a93-47d4-b9e7-d1d5b2a0b3a6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fluticasone Propionate
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Sam's West, Inc
- Application
- ANDA208150
- Marketing category
- ANDA
- Marketing start
- 2025-07-01
- 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 |
|---|
| 68196-503-01 | Fluticasone Propionate | 1 in 1 CARTON | SPRAY, METERED | 1 | | 5 |
| 68196-503-02 | Fluticasone Propionate | 144 in 1 BOTTLE, SPRAY | SPRAY, METERED | 144 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68196-503 | FLUTICASONE PROPIONATE SPRAY, METERED [SAM'S WEST INC.] | 2 | Current NDC, 2 package rows | 20241004_d2a6e22c-1159-c86a-b927-e7ace1d7023f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68196-503-01 | 68196050301 | 1 BOTTLE, SPRAY in 1 CARTON (68196-503-01) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY (68196-503-02) | 2025-07-01 | No | No | Current |
| 68196-503-02 | 68196050302 | 144 in 1 BOTTLE, SPRAY | | | | Historical |