Home NDC 63402-701 Omnaris
Product NDC 63402-701
11-digit product format 634020701
Labeler code 63402
Product ID 63402-701_af866970-b12f-4c99-b745-62a2bc2cf5b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ciclesonide
Dosage form SPRAY
Route NASAL
Labeler Sunovion Pharmaceuticals Inc.
Application NDA022004
Marketing category NDA
Marketing start 2008-03-01
Marketing end 2019-12-01
Substance CICLESONIDE
Active strength 50 ug/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ciclesonide ACTIVE INGREDIENT S59502J185 OMNARIS (CICLESONIDE) SPRAY [SUNOVION PHARMACEUTICALS INC.] 10 ciclesonide ACTIVE MOIETY S59502J185 OMNARIS (CICLESONIDE) SPRAY [SUNOVION PHARMACEUTICALS INC.] 10 Carboxymethylcellulose sodium INACTIVE INGREDIENT K679OBS311 OMNARIS (CICLESONIDE) SPRAY [SUNOVION PHARMACEUTICALS INC.] 10 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U OMNARIS (CICLESONIDE) SPRAY [SUNOVION PHARMACEUTICALS INC.] 10 Edetate disodium INACTIVE INGREDIENT 7FLD91C86K OMNARIS (CICLESONIDE) SPRAY [SUNOVION PHARMACEUTICALS INC.] 10 Hydrochloric acid INACTIVE INGREDIENT QTT17582CB OMNARIS (CICLESONIDE) SPRAY [SUNOVION PHARMACEUTICALS INC.] 10 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO OMNARIS (CICLESONIDE) SPRAY [SUNOVION PHARMACEUTICALS INC.] 10 Potassium sorbate INACTIVE INGREDIENT 1VPU26JZZ4 OMNARIS (CICLESONIDE) SPRAY [SUNOVION PHARMACEUTICALS INC.] 10 water INACTIVE INGREDIENT 059QF0KO0R OMNARIS (CICLESONIDE) SPRAY [SUNOVION PHARMACEUTICALS INC.] 10 CICLESONIDE ACTIVE INGREDIENT S59502J185 OMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.] 1 CICLESONIDE ACTIVE MOIETY S59502J185 OMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 OMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.] 1 EDETATE SODIUM INACTIVE INGREDIENT MP1J8420LU OMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB OMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO OMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 OMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.] 1
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Omnaris CICLESONIDE Covis Pharma US, Inc 15fefd46-ac7e-40d0-b635-e6c3d653c666 2022-11-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 022004 application number: NDA022004
DailyMed RxNorm Mappings#