Fluticasone Propionate and Salmeterol
- Product NDC
- 0093-3608
- 11-digit product format
- 000933608
- Labeler code
- 0093
- Product ID
- 0093-3608_f09e7a41-3e53-48b2-ab31-a249f4fb28ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluticasone Propionate and Salmeterol
- Dosage form
- POWDER, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- NDA208799
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2017-04-28
- Substance
- FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
- Active strength
- 113; 14 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 | 113 ug/1 |
| SALMETEROL XINAFOATE | 14 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O2GMZ0LF5W, 6EW8Q962A5 |
| Rxcui | 1918194, 1918203, 1918209 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-3608-82 | Fluticasone Propionate and Salmeterol | 1 in 1 CARTON | POWDER, METERED | 1 | | 18 |
| 0093-3608-82 | Fluticasone Propionate and Salmeterol | 1 in 1 POUCH | POWDER, METERED | 1 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-3608 | FLUTICASONE PROPIONATE AND SALMETEROL POWDER, METERED [TEVA PHARMACEUTICALS USA, INC.] | 18 | Current NDC, Legacy NDC, 2 package rows | 20240210_43a27267-2f2b-410d-9c30-9cb95f35d9a1.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1918194 | fluticasone propionate/salmeterol 113/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 84654ac7-e2b4-4fa1-b127-69aee03aecc0 | 103 |
| 1918194 | 60 ACTUAT fluticasone propionate 0.113 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler | SCD | 84654ac7-e2b4-4fa1-b127-69aee03aecc0 | 103 |
| 1918194 | fluticasone propionate 113 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATS | SY | 84654ac7-e2b4-4fa1-b127-69aee03aecc0 | 103 |
| 1918194 | fluticasone propionate/salmeterol 113/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 77269609-fb89-47c7-97cc-22e0183e91ae | 25 |
| 1918203 | fluticasone propionate/salmeterol 232/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 77269609-fb89-47c7-97cc-22e0183e91ae | 25 |
| 1918209 | fluticasone propionate/salmeterol 55/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 77269609-fb89-47c7-97cc-22e0183e91ae | 25 |
| 1918209 | 60 ACTUAT fluticasone propionate 0.055 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler | SCD | 77269609-fb89-47c7-97cc-22e0183e91ae | 25 |
| 1918194 | 60 ACTUAT fluticasone propionate 0.113 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler | SCD | 77269609-fb89-47c7-97cc-22e0183e91ae | 25 |
| 1918203 | 60 ACTUAT fluticasone propionate 0.232 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler | SCD | 77269609-fb89-47c7-97cc-22e0183e91ae | 25 |
| 1918194 | fluticasone propionate 113 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATS | SY | 77269609-fb89-47c7-97cc-22e0183e91ae | 25 |
| 1918203 | fluticasone propionate 232 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATS | SY | 77269609-fb89-47c7-97cc-22e0183e91ae | 25 |
| 1918209 | fluticasone propionate 55 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATS | SY | 77269609-fb89-47c7-97cc-22e0183e91ae | 25 |
| 1918194 | fluticasone propionate/salmeterol 113/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 43a27267-2f2b-410d-9c30-9cb95f35d9a1 | 18 |
| 1918203 | fluticasone propionate/salmeterol 232/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 43a27267-2f2b-410d-9c30-9cb95f35d9a1 | 18 |
| 1918209 | fluticasone propionate/salmeterol 55/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 43a27267-2f2b-410d-9c30-9cb95f35d9a1 | 18 |
| 1918209 | 60 ACTUAT fluticasone propionate 0.055 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler | SCD | 43a27267-2f2b-410d-9c30-9cb95f35d9a1 | 18 |
| 1918194 | 60 ACTUAT fluticasone propionate 0.113 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler | SCD | 43a27267-2f2b-410d-9c30-9cb95f35d9a1 | 18 |
| 1918203 | 60 ACTUAT fluticasone propionate 0.232 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler | SCD | 43a27267-2f2b-410d-9c30-9cb95f35d9a1 | 18 |
| 1918194 | fluticasone propionate 113 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATS | SY | 43a27267-2f2b-410d-9c30-9cb95f35d9a1 | 18 |
| 1918203 | fluticasone propionate 232 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATS | SY | 43a27267-2f2b-410d-9c30-9cb95f35d9a1 | 18 |
| 1918209 | fluticasone propionate 55 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATS | SY | 43a27267-2f2b-410d-9c30-9cb95f35d9a1 | 18 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-3608-82 | 00093360882 | 1 POUCH in 1 CARTON (0093-3608-82) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER | 1 pouch | 2017-04-28 | 0000-00-00 | No | No | Current |