Prescription drug · ANDA
Wixela Inhub (Fluticasone propionate and salmeterol) NDC 0378-9322
Fluticasone propionate 500 ug/1; Salmeterol xinafoate 50 ug/1 · Powder · Respiratory (Inhalation) · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-9322-32 | 00378932232 | 1 INHALER in 1 CARTON (0378-9322-32) / 60 POWDER in 1 INHALERMarketed from Feb 11, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Wixela Inhub
- Generic name (nonproprietary)
- fluticasone propionate and salmeterol
- Active ingredients
- Fluticasone propionate — 500 ug/1Salmeterol xinafoate — 50 ug/1
- Dosage form
- Powder
- Route
- Respiratory (Inhalation)
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208891
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0378-9322_03d33612-03b4-4a2c-ba86-47816db363ceSPL ID 03d33612-03b4-4a2c-ba86-47816db363ceSPL set ID 3beef422-8a07-4a45-9ba6-414511e4b7e2RxCUI 896184, 896209, 896228, 2110510, 2110513, 2110516UNII 6EW8Q962A5, O2GMZ0LF5W
- Pharmacologic class
- Corticosteroid; beta2-Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N400378932232followed by a unit qualifier and the quantityPackage 00378-9322-32. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Wixela Inhub ® is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: • Twice-daily treatment of asthma in patients aged 4 years and older. ( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). ( 1.2 ) Important limitation of use: Not indicated for relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma Wixela Inhub ® is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Wixela Inhub ® should be used for patients not adequately controlled on a long-term asthma control medication such as an in…
Excerpt only. Read the full label for complete information.
About NDC 0378-9322
- What is NDC 0378-9322?
- 0378-9322 is the product NDC for Wixela Inhub, Fluticasone propionate 500 ug/1; Salmeterol xinafoate 50 ug/1 powder, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Wixela Inhub (Fluticasone propionate and salmeterol).
- What is the active ingredient?
- Fluticasone propionate, Salmeterol xinafoate.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Wixela Inhub?
- 3 other product NDCs are listed under this name. See all Wixela Inhub NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Wixela Inhub products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Wixela Inhubfluticasone propionate and salmeterol | Fluticasone propionate 100 ug/1; Salmeterol xinafoate 50 ug/1 | PowderRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-9320 | 00378-9320-32 |
| Wixela Inhubfluticasone propionate and salmeterol | Fluticasone propionate 250 ug/1; Salmeterol xinafoate 50 ug/1 | PowderRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-9321 | 00378-9321-32 |
| Wixela Inhubfluticasone propionate and salmeterol | Fluticasone propionate 250 ug/1; Salmeterol xinafoate 50 ug/1 | PowderRespiratory (Inhalation) | Bryant Ranch Prepack | 63629-4989 | 63629-4989-01 |
Other NDCs under ANDA 208891
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Wixela Inhubfluticasone propionate and salmeterol | Fluticasone propionate 100 ug/1; Salmeterol xinafoate 50 ug/1 | PowderRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-9320 |
| Wixela Inhubfluticasone propionate and salmeterol | Fluticasone propionate 250 ug/1; Salmeterol xinafoate 50 ug/1 | PowderRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-9321 |
| Wixela Inhubfluticasone propionate and salmeterol | Fluticasone propionate 250 ug/1; Salmeterol xinafoate 50 ug/1 | PowderRespiratory (Inhalation) | Bryant Ranch Prepack | 63629-4989 |