fluticasone propionate and salmeterol
- Product NDC
- 0054-0328
- 11-digit product format
- 000540328
- Labeler code
- 0054
- Product ID
- 0054-0328_e2206df8-d8d5-4bef-beff-e70c42419d01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluticasone propionate and salmeterol
- Dosage form
- POWDER
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA203433
- Marketing category
- ANDA
- Marketing start
- 2020-12-17
- Substance
- FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
- Active strength
- 500; 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- fluticasone propionate and salmeterol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUTICASONE PROPIONATE | 500 ug/1 |
| SALMETEROL XINAFOATE | 50 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6EW8Q962A5, O2GMZ0LF5W |
| Rxcui | 896184, 896209, 896228 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0328-56 | fluticasone propionate and salmeterol | 1 in 1 CARTON | POWDER | 1 | | 7 |
| 0054-0328-56 | fluticasone propionate and salmeterol | 1 in 1 POUCH | POWDER | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0328 | FLUTICASONE PROPIONATE AND SALMETEROL POWDER [HIKMA PHARMACEUTICALS USA INC.] | 7 | Current NDC, 2 package rows | 20241207_f9fcfc90-3677-4a9b-900e-44417d50d507.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 896184 | fluticasone propionate/salmeterol 100/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters | PSN | f9fcfc90-3677-4a9b-900e-44417d50d507 | 7 |
| 896209 | fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters | PSN | f9fcfc90-3677-4a9b-900e-44417d50d507 | 7 |
| 896228 | fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters | PSN | f9fcfc90-3677-4a9b-900e-44417d50d507 | 7 |
| 896184 | 60 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler | SCD | f9fcfc90-3677-4a9b-900e-44417d50d507 | 7 |
| 896209 | 60 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler | SCD | f9fcfc90-3677-4a9b-900e-44417d50d507 | 7 |
| 896228 | 60 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler | SCD | f9fcfc90-3677-4a9b-900e-44417d50d507 | 7 |
| 896184 | fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | f9fcfc90-3677-4a9b-900e-44417d50d507 | 7 |
| 896209 | fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | f9fcfc90-3677-4a9b-900e-44417d50d507 | 7 |
| 896228 | fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | f9fcfc90-3677-4a9b-900e-44417d50d507 | 7 |
| 896184 | fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | f9fcfc90-3677-4a9b-900e-44417d50d507 | 7 |
| 896209 | fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | f9fcfc90-3677-4a9b-900e-44417d50d507 | 7 |
| 896228 | fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | f9fcfc90-3677-4a9b-900e-44417d50d507 | 7 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0054-0328-56 | 00054032856 | 1 POUCH in 1 CARTON (0054-0328-56) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER | 1 pouch | 2023-12-19 | No | No | Historical |