omnaris

Generic: ciclesonide

Labeler: covis pharma us, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name omnaris
Generic Name ciclesonide
Labeler covis pharma us, inc
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

ciclesonide 50 ug/1

Manufacturer
Covis Pharma US, Inc

Identifiers & Regulatory

Product NDC 70515-701
Product ID 70515-701_fa248cfa-08c9-43a3-8289-a28e5447cb1d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022004
Listing Expiration 2026-12-31
Marketing Start 2018-04-23

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70515701
Hyphenated Format 70515-701

Supplemental Identifiers

RxCUI
1797841 1797843
UNII
S59502J185

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name omnaris (source: ndc)
Generic Name ciclesonide (source: ndc)
Application Number NDA022004 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 50 ug/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (70515-701-01) / 1 BOTTLE, GLASS in 1 POUCH / 120 SPRAY in 1 BOTTLE, GLASS
source: ndc

Packages (1)

70515-701-01 1 POUCH in 1 CARTON (70515-701-01) / 1 BOTTLE, GLASS in 1 POUCH / 120 SPRAY in 1 BOTTLE, GLASS

Ingredients (1)

ciclesonide (50 ug/1)

Linked Drug Pages (1)

Omnaris ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "fa248cfa-08c9-43a3-8289-a28e5447cb1d", "openfda": {"unii": ["S59502J185"], "rxcui": ["1797841", "1797843"], "spl_set_id": ["15fefd46-ac7e-40d0-b635-e6c3d653c666"], "manufacturer_name": ["Covis Pharma US, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (70515-701-01)  / 1 BOTTLE, GLASS in 1 POUCH / 120 SPRAY in 1 BOTTLE, GLASS", "package_ndc": "70515-701-01", "marketing_start_date": "20180423"}], "brand_name": "Omnaris", "product_id": "70515-701_fa248cfa-08c9-43a3-8289-a28e5447cb1d", "dosage_form": "SPRAY", "product_ndc": "70515-701", "generic_name": "ciclesonide", "labeler_name": "Covis Pharma US, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omnaris", "active_ingredients": [{"name": "CICLESONIDE", "strength": "50 ug/1"}], "application_number": "NDA022004", "marketing_category": "NDA", "marketing_start_date": "20180423", "listing_expiration_date": "20261231"}