Prescription drug · NDA
Omnaris (Ciclesonide) NDC 70515-701
Ciclesonide 50 ug/1 · Spray · Nasal · Covis Pharma US, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70515-701-01 | 70515070101 | 1 POUCH in 1 CARTON (70515-701-01) / 1 BOTTLE, GLASS in 1 POUCH / 120 SPRAY in 1 BOTTLE, GLASSMarketed from Apr 23, 2018 |
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)
- Omnaris
- Generic name (nonproprietary)
- ciclesonide
- Active ingredients
- Ciclesonide — 50 ug/1
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Covis Pharma US, IncNDC labeler code 70515
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022004
- Marketing start
- Listing expires
- Identifiers
- Product ID 70515-701_fa248cfa-08c9-43a3-8289-a28e5447cb1dSPL ID fa248cfa-08c9-43a3-8289-a28e5447cb1dSPL set ID 15fefd46-ac7e-40d0-b635-e6c3d653c666RxCUI 1797841, 1797843UNII 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 HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470515070101followed by a unit qualifier and the quantityPackage 70515-0701-01. 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)
OMNARIS Nasal Spray is a corticosteroid indicated for treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older and perennial allergic rhinitis in adults and adolescents 12 years of age and older. ( 1.1 , 1.2 ) 1.1 Treatment of Seasonal Allergic Rhinitis OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. 1.2 Treatment of Perennial Allergic Rhinitis OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with perennial allergic rhinitis in adults and adolescents 12 years of age and older.…
Excerpt only. Read the full label for complete information.
About NDC 70515-701
- What is NDC 70515-701?
- 70515-701 is the product NDC for Omnaris (ciclesonide), Ciclesonide 50 ug/1 spray, listed with the FDA by Covis Pharma US, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omnaris (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 Omnaris?
- 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.