Prescription drug · NDA AUTHORIZED GENERIC
Fluticasone Propionate and Salmeterol NDC 63629-8810
Fluticasone propionate 232 ug/1; Salmeterol xinafoate 14 ug/1 · Powder, Metered · Respiratory (Inhalation) · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8810-1 | 6362988100163629881001 | 1 POUCH in 1 CARTON (63629-8810-1) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALERMarketed from Apr 28, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Fluticasone propionate — 232 ug/1Salmeterol xinafoate — 14 ug/1
- Dosage form
- Powder, Metered
- Route
- Respiratory (Inhalation)
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 208799
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63629-8810_9e637ba7-f645-48c3-8603-c1bbb0765a65SPL ID 9e637ba7-f645-48c3-8603-c1bbb0765a65SPL set ID f3bce31d-93f9-4ca6-835e-b16e2d31b6c5RxCUI 1918203UNII 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
N463629881001followed by a unit qualifier and the quantityPackage 63629-8810-01. 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/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. Fluticasone Propionate/Salmeterol MDPI should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta 2 -adrenergic agonist (LABA). Limitations of Use : Fluticasone Propionate/Salmeterol MDPI is not indicated for the relief of acute bronchospasm. Fluticasone Propionate/Salmeterol Multi-Dose Dry Powder Inhaler (MDPI) is a combination of fluticasone propio…
Excerpt only. Read the full label for complete information.
About NDC 63629-8810
- What is NDC 63629-8810?
- 63629-8810 is the product NDC for Fluticasone Propionate and Salmeterol, Fluticasone propionate 232 ug/1; Salmeterol xinafoate 14 ug/1 powder, metered, listed with the FDA by Bryant Ranch Prepack. 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?
- Fluticasone propionate, Salmeterol xinafoate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 NDA 208799
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 | Fluticasone propionate 113 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-3608 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 55 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-3607 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 232 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-3609 |
| AirDuo RespiClickfluticasone propionate and salmeterol | Fluticasone propionate 232 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Teva Respiratory, LLC | 59310-822 |
| AirDuo RespiClickfluticasone propionate and salmeterol | Fluticasone propionate 55 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Teva Respiratory, LLC | 59310-805 |
| AirDuo RespiClickfluticasone propionate and salmeterol | Fluticasone propionate 113 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Teva Respiratory, LLC | 59310-812 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 55 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Bryant Ranch Prepack | 63629-8811 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 113 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | Bryant Ranch Prepack | 63629-8809 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 113 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | A-S Medication Solutions | 50090-3271 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 55 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | A-S Medication Solutions | 50090-3272 |
| Fluticasone Propionate and Salmeterol | Fluticasone propionate 232 ug/1; Salmeterol xinafoate 14 ug/1 | Powder, MeteredRespiratory (Inhalation) | A-S Medication Solutions | 50090-3387 |