Prescription drug · NDA
Alvesco (Ciclesonide) NDC 70515-711
Ciclesonide 80 ug/1 · Aerosol, Metered · Respiratory (Inhalation) · Covis Pharma US, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70515-711-01 | 70515071101 | 1 INHALER in 1 CARTON (70515-711-01) / 60 AEROSOL, METERED in 1 INHALERMarketed from Mar 26, 2018 | |
| 70515-711-02 | 70515071102 | 1 INHALER in 1 CARTON (70515-711-02) / 60 AEROSOL, METERED in 1 INHALERMarketed from Mar 26, 2018 · Sample package | |
| 70515-711-03 | 70515071103 | 1 INHALER in 1 CARTON (70515-711-03) / 30 AEROSOL, METERED in 1 INHALERMarketed from Apr 30, 2021 | |
| 70515-711-04 | 70515071104 | 1 INHALER in 1 CARTON (70515-711-04) / 30 AEROSOL, METERED in 1 INHALERMarketed from Apr 30, 2021 | |
| 70515-711-05 | 70515071105 | 1 INHALER in 1 CARTON (70515-711-05) / 60 AEROSOL, METERED in 1 INHALERMarketed from Apr 30, 2021 |
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)
- Alvesco
- Generic name (nonproprietary)
- ciclesonide
- Active ingredients
- Ciclesonide — 80 ug/1
- Dosage form
- Aerosol, Metered
- Route
- Respiratory (Inhalation)
- Labeler
- Covis Pharma US, IncNDC labeler code 70515
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021658
- Marketing start
- Listing expires
- Identifiers
- Product ID 70515-711_3a8b4338-890b-bc2f-e063-6394a90ab578SPL ID 3a8b4338-890b-bc2f-e063-6394a90ab578SPL set ID 9f6112fb-78ef-43cf-8ae3-36370eb45468RxCUI 799034, 799037, 799038, 799040UNII S59502J185
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
N470515071101followed by a unit qualifier and the quantityPackage 70515-0711-01. 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)
ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use : ALVESCO is not indicated for the relief of acute bronchospasm. ALVESCO is not indicated for children under 12 years of age. ALVESCO is an inhaled corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. ( 1 ) Limitations of Use : ALVESCO is not indicated for the relief of acute bronchospasm or in pediatric patients less than 12 years of age. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 70515-711
- What is NDC 70515-711?
- 70515-711 is the product NDC for Alvesco (ciclesonide), Ciclesonide 80 ug/1 aerosol, metered, listed with the FDA by Covis Pharma US, Inc. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alvesco (Ciclesonide).
- What is the active ingredient?
- Ciclesonide.
- Who is the labeler?
- Covis Pharma US, Inc, NDC labeler code 70515. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alvesco?
- 1 other product NDC are listed under this name. See all Alvesco NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alvesco products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alvescociclesonide | Ciclesonide 160 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Covis Pharma US, Inc | 70515-712 | 70515-0712-0170515-0712-0270515-0712-03+2 more |
Other NDCs under NDA 021658
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 |
|---|---|---|---|---|
| Alvescociclesonide | Ciclesonide 160 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Covis Pharma US, Inc | 70515-712 |