NDC codes

FDA NDC Directory
Product NDC (as listed)70515-701Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70515-0701Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70515-701-01705150701011 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

N470515070101 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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