Prescription drug · NDA
Serevent Diskus (Salmeterol xinafoate) NDC 0173-0521
Salmeterol xinafoate 50 ug/1 · Powder, Metered · Oral, Respiratory (Inhalation) · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0521-00 | 00173052100 | 1 INHALER in 1 CARTON (0173-0521-00) / 60 POWDER, METERED in 1 INHALERMarketed from Nov 25, 1997 |
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)
- Serevent DiskusSuffix: DISKUS
- Generic name (nonproprietary)
- salmeterol xinafoate
- Active ingredients
- Salmeterol xinafoate — 50 ug/1
- Dosage form
- Powder, Metered
- Route
- Oral, Respiratory (Inhalation)
- Labeler
- GlaxoSmithKline LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020692
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 0173-0521_58899d4d-8769-43e0-94aa-3002f4097f9aSPL ID 58899d4d-8769-43e0-94aa-3002f4097f9aSPL set ID 12d9728e-6b5c-4aee-bfb0-745e542ed2e4RxCUI 866048, 866049UNII 6EW8Q962A5
- Pharmacologic class
- 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
N400173052100followed by a unit qualifier and the quantityPackage 00173-0521-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
SEREVENT DISKUS is a LABA indicated for: • Treatment of asthma in patients aged 4 years and older with an ICS. ( 1.1 ) • Prevention of exercise-induced bronchospasm (EIB) in patients aged 4 years and older. ( 1.2 ) • Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). ( 1.3 ) Important limitation of use: Not indicated for relief of acute bronchospasm. ( 1.1 , 1.3 ) 1.1 Treatment of Asthma SEREVENT DISKUS is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with an ICS in patients aged 4 years and older with reversible obstructive airway disease, including patients with symptoms of nocturnal …
Excerpt only. Read the full label for complete information.
About NDC 0173-0521
- What is NDC 0173-0521?
- 0173-0521 is the product NDC for Serevent Diskus (salmeterol xinafoate), Salmeterol xinafoate 50 ug/1 powder, metered, listed with the FDA by GlaxoSmithKline LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Serevent Diskus (Salmeterol xinafoate).
- What is the active ingredient?
- Salmeterol xinafoate.
- Who is the labeler?
- GlaxoSmithKline LLC, NDC labeler code 0173. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Serevent Diskus?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.