Prescription drug · ANDA
fluticasone propionate and salmeterol NDC 0054-0328
Salmeterol xinafoate 50 ug/1; Fluticasone propionate 500 ug/1 · Powder · Respiratory (Inhalation) · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0328-56 | 0005403285600054032856 | 1 POUCH in 1 CARTON (0054-0328-56) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALERMarketed from Dec 19, 2023 |
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)
- fluticasone propionate and salmeterol
- Generic name (nonproprietary)
- fluticasone propionate and salmeterol
- Active ingredients
- Salmeterol xinafoate — 50 ug/1Fluticasone propionate — 500 ug/1
- Dosage form
- Powder
- Route
- Respiratory (Inhalation)
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203433
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0054-0328_e2206df8-d8d5-4bef-beff-e70c42419d01SPL ID e2206df8-d8d5-4bef-beff-e70c42419d01SPL set ID f9fcfc90-3677-4a9b-900e-44417d50d507RxCUI 896184, 896209, 896228UNII O2GMZ0LF5W, 6EW8Q962A5
- 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
N400054032856followed by a unit qualifier and the quantityPackage 00054-0328-56. 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)
Fluticasone propionate and salmeterol inhalation powder 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 Fluticasone propionate and salmeterol inhalation powder is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Fluticasone propionate and salmeterol inh…
Excerpt only. Read the full label for complete information.
About NDC 0054-0328
- What is NDC 0054-0328?
- 0054-0328 is the product NDC for fluticasone propionate and salmeterol, Salmeterol xinafoate 50 ug/1; Fluticasone propionate 500 ug/1 powder, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- fluticasone propionate and salmeterol.
- What is the active ingredient?
- Salmeterol xinafoate, Fluticasone propionate.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for fluticasone propionate and salmeterol?
- 23 other product NDCs are listed under this name. See all fluticasone propionate and salmeterol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other fluticasone propionate and salmeterol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluticasone propionate and Salmeterol | Fluticasone propionate 250 ug/1; Salmeterol xinafoate 50 ug/1 | PowderRespiratory (Inhalation) | Cipla USA Inc. | 69097-661 | 69097-0661-03 |
| Fluticasone propionate and Salmeterol | Fluticasone propionate 100 ug/1; Salmeterol xinafoate 50 ug/1 | PowderRespiratory (Inhalation) | Cipla USA Inc. | 69097-662 | 69097-0662-03 |
| Fluticasone propionate and Salmeterol | Fluticasone propionate 500 ug/1; Salmeterol xinafoate 50 ug/1 | PowderRespiratory (Inhalation) | Cipla USA Inc. | 69097-663 | 69097-0663-03 |
| Fluticasone Propionate and Salmeterol | Salmeterol xinafoate 50 ug/1; Fluticasone propionate 100 ug/1 | PowderRespiratory (Inhalation) | Lannett Company, Inc. | 0527-6010 | 00527-6010-06 |
| fluticasone propionate and salmeterol | Salmeterol xinafoate 50 ug/1; Fluticasone propionate 100 ug/1 | PowderRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-4406 | 70518-4406-00 |
| Fluticasone Propionate and Salmeterol | Salmeterol xinafoate 50 ug/1; Fluticasone propionate 250 ug/1 | PowderRespiratory (Inhalation) | Lannett Company, Inc. | 0527-6011 | 00527-6011-06 |
| fluticasone propionate and salmeterol | Salmeterol xinafoate 50 ug/1; Fluticasone propionate 100 ug/1 | PowderRespiratory (Inhalation) | Preferred Pharmaceuticals Inc. | 68788-8704 | 68788-8704-06 |
| fluticasone propionate and salmeterol | Salmeterol xinafoate 50 ug/1; Fluticasone propionate 250 ug/1 | PowderRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-3968 | 70518-3968-00 |
| fluticasone propionate and salmeterol | Salmeterol xinafoate 50 ug/1; Fluticasone propionate 250 ug/1 | PowderRespiratory (Inhalation) | Preferred Pharmaceuticals Inc. | 68788-8453 | 68788-8453-06 |
| fluticasone propionate and salmeterol | Fluticasone propionate 500 ug/1; Salmeterol xinafoate 50 ug/1 | PowderRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-7516 | 00093-7516-31 |
Other NDCs under ANDA 203433
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 |
|---|---|---|---|---|
| fluticasone propionate and salmeterol | Salmeterol xinafoate 50 ug/1; Fluticasone propionate 100 ug/1 | PowderRespiratory (Inhalation) | Hikma Pharmaceuticals USA Inc. | 0054-0326 |
| fluticasone propionate and salmeterol | Salmeterol xinafoate 50 ug/1; Fluticasone propionate 250 ug/1 | PowderRespiratory (Inhalation) | Hikma Pharmaceuticals USA Inc. | 0054-0327 |
| fluticasone propionate and salmeterol | Salmeterol xinafoate 50 ug/1; Fluticasone propionate 250 ug/1 | PowderRespiratory (Inhalation) | Preferred Pharmaceuticals Inc. | 68788-8453 |
| fluticasone propionate and salmeterol | Salmeterol xinafoate 50 ug/1; Fluticasone propionate 100 ug/1 | PowderRespiratory (Inhalation) | Preferred Pharmaceuticals Inc. | 68788-8704 |
| fluticasone propionate and salmeterol | Salmeterol xinafoate 50 ug/1; Fluticasone propionate 250 ug/1 | PowderRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-3968 |
| fluticasone propionate and salmeterol | Salmeterol xinafoate 50 ug/1; Fluticasone propionate 100 ug/1 | PowderRespiratory (Inhalation) | REMEDYREPACK INC. | 70518-4406 |