Omnaris
- Product NDC
- 70515-701
- 11-digit product format
- 705150701
- Labeler code
- 70515
- Product ID
- 70515-701_fa248cfa-08c9-43a3-8289-a28e5447cb1d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ciclesonide
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Covis Pharma US, Inc
- Application
- NDA022004
- Marketing category
- NDA
- Marketing start
- 2018-04-23
- Substance
- CICLESONIDE
- Active strength
- 50 ug/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omnaris
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CICLESONIDE | 50 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S59502J185 |
| Rxcui | 1797841, 1797843 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70515-701-01 | Omnaris | 1 in 1 POUCH | SPRAY | 1 | | 5 |
| 70515-701-01 | Omnaris | 1 in 1 CARTON | SPRAY | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70515-701 | OMNARIS (CICLESONIDE) SPRAY [COVIS PHARMA US, INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20221208_15fefd46-ac7e-40d0-b635-e6c3d653c666.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70515-701-01 | 70515070101 | 1 POUCH in 1 CARTON (70515-701-01) / 1 BOTTLE, GLASS in 1 POUCH / 120 SPRAY in 1 BOTTLE, GLASS | 1 pouch | 2018-04-23 | 0000-00-00 | No | No | Current |