Wixela Inhub
- Product NDC
- 0378-9320
- 11-digit product format
- 003789320
- Labeler code
- 0378
- Product ID
- 0378-9320_03d33612-03b4-4a2c-ba86-47816db363ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluticasone propionate and salmeterol
- Dosage form
- POWDER
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA208891
- Marketing category
- ANDA
- Marketing start
- 2019-02-11
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Wixela Inhub
- Listing expiration
- 2026-12-31
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, 896228, 2110510, 2110513, 2110516 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-9320-32 | Wixela Inhub | 60 in 1 INHALER | POWDER | 60 | | 6 |
| 0378-9320-32 | Wixela Inhub | 1 in 1 CARTON | POWDER | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-9320 | WIXELA INHUB (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [MYLAN PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20220911_3beef422-8a07-4a45-9ba6-414511e4b7e2.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 | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 896209 | fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters | PSN | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 896228 | fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters | PSN | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 2110510 | Wixela Inhub 100/50 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 2110513 | Wixela Inhub 250/50 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 2110516 | Wixela Inhub 500/50 MCG/INHAL Dry Powder Inhaler, 60 Actuations | PSN | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 2110510 | 60 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Wixela] | SBD | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 2110513 | 60 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Wixela] | SBD | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 2110516 | 60 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Wixela] | SBD | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 896184 | 60 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler | SCD | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 896209 | 60 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler | SCD | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 896228 | 60 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler | SCD | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 896184 | fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 896209 | fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 896228 | fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 896184 | fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 896209 | fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 896228 | fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 2110510 | Wixela Inhub 100/50 MCG/INHAL Dry Powder Inhaler, 60 Actuations | SY | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 2110513 | Wixela Inhub 250/50 MCG/INHAL Dry Powder Inhaler, 60 Actuations | SY | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
| 2110516 | Wixela Inhub 500/50 MCG/INHAL Dry Powder Inhaler, 60 Actuations | SY | 3beef422-8a07-4a45-9ba6-414511e4b7e2 | 6 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-9320-32 | 00378932032 | 1 INHALER in 1 CARTON (0378-9320-32) / 60 POWDER in 1 INHALER | 1 inhaler | 2019-02-11 | 0000-00-00 | No | No | Current |