Home NDC 70515-701 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022004-001 OMNARIS CICLESONIDE 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022004-001 8371292 2028-02-01 U-1356
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 2 · 63 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S59502J185 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797841 Internal RxNorm lookup 1797843 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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