Prescription drug · NDA AUTHORIZED GENERIC
Fluticasone Propionate and Salmeterol HFA NDC 66993-088
fluticasone propionate and salmeterol xinafoate · Fluticasone propionate 230 ug/1; Salmeterol xinafoate 21 ug/1 · Aerosol, Metered · Respiratory (Inhalation) · Prasco Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66993-088-96 | 66993008896 | 1 INHALER in 1 CARTON (66993-088-96) / 120 AEROSOL, METERED in 1 INHALERMarketed from Mar 1, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 HFA
- Generic name (nonproprietary)
- fluticasone propionate and salmeterol xinafoate
- Active ingredients
- Fluticasone propionate — 230 ug/1Salmeterol xinafoate — 21 ug/1
- Dosage form
- Aerosol, Metered
- Route
- Respiratory (Inhalation)
- Labeler
- Prasco Laboratories
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021254
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 66993-088_7a85b8b8-7336-4563-9cf7-a03693e08f70SPL ID 7a85b8b8-7336-4563-9cf7-a03693e08f70SPL set ID 666c5b12-a4f7-4c53-8261-4742b5e5a6dfRxCUI 896236, 896244, 896272UNII 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
N466993008896followed by a unit qualifier and the quantityPackage 66993-0088-96. 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 HFA is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. Fluticasone Propionate and Salmeterol HFA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta 2 -adrenergic agonist (LABA). Limitations of Use Fluticasone Propionate and Salmeterol HFA is not indicated for the relief of acute bronchospasm. Fluticasone Propionate and Salmeterol HFA is a combination of fluticasone propionate, an inhaled corticosteroid, and salmeterol, a long-acting beta 2 ‑a…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021254
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 |
|---|---|---|---|---|
| Advair HFAfluticasone propionate and salmeterol xinafoate | Fluticasone propionate 115 ug/1; Salmeterol xinafoate 21 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | A-S Medication Solutions | 50090-4504 |
| Advair HFAfluticasone propionate and salmeterol xinafoate | Fluticasone propionate 45 ug/1; Salmeterol xinafoate 21 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | GlaxoSmithKline LLC | 0173-0715 |
| Advair HFAfluticasone propionate and salmeterol xinafoate | Fluticasone propionate 115 ug/1; Salmeterol xinafoate 21 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | GlaxoSmithKline LLC | 0173-0716 |
| Advair HFAfluticasone propionate and salmeterol xinafoate | Fluticasone propionate 230 ug/1; Salmeterol xinafoate 21 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | GlaxoSmithKline LLC | 0173-0717 |
| Fluticasone Propionate and Salmeterol HFAfluticasone propionate and salmeterol xinafoate | Fluticasone propionate 45 ug/1; Salmeterol xinafoate 21 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Prasco Laboratories | 66993-086 |
| Fluticasone Propionate and Salmeterol HFAfluticasone propionate and salmeterol xinafoate | Fluticasone propionate 115 ug/1; Salmeterol xinafoate 21 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Prasco Laboratories | 66993-087 |
| Advair HFAfluticasone propionate and salmeterol xinafoate | Fluticasone propionate 115 ug/1; Salmeterol xinafoate 21 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | A-S Medication Solutions | 50090-3672 |