Fluticasone Propionate and Salmeterol
- Product NDC
- 0527-6010
- 11-digit product format
- 005276010
- Labeler code
- 0527
- Product ID
- 0527-6010_f418af21-42ab-4af0-bc6f-1079059c07fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluticasone propionate and salmeterol
- Dosage form
- POWDER
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Lannett Company, Inc.
- Application
- ANDA214464
- Marketing category
- ANDA
- Marketing start
- 2026-01-12
- Substance
- FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
- Active strength
- 100; 50 ug/1; ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluticasone Propionate and Salmeterol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUTICASONE PROPIONATE | 100 ug/1 |
| SALMETEROL XINAFOATE | 50 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6EW8Q962A5, O2GMZ0LF5W |
| Rxcui | 896184, 896209 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0527-6010-06 | Fluticasone Propionate and Salmeterol | 60 in 1 INHALER | POWDER | 60 | | 7 |
| 0527-6010-06 | Fluticasone Propionate and Salmeterol | 1 in 1 CARTON | POWDER | 1 | | 7 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0527-6010-06 | 00527601006 | 1 INHALER in 1 CARTON (0527-6010-06) / 60 POWDER in 1 INHALER | 1 inhaler | 2026-01-12 | No | No | Current |