NDC 63402-701

Omnaris

Ciclesonide

Omnaris is a Nasal Spray in the Human Prescription Drug category. It is labeled and distributed by Sunovion Pharmaceuticals . The primary component is Ciclesonide.

Product ID63402-701_5f5cd2a6-030f-48d6-b7da-b60ff8bf7412
NDC63402-701
Product TypeHuman Prescription Drug
Proprietary NameOmnaris
Generic NameCiclesonide
Dosage FormSpray
Route of AdministrationNASAL
Marketing Start Date2008-03-01
Marketing CategoryNDA / NDA
Application NumberNDA022004
Labeler NameSunovion Pharmaceuticals
Substance NameCICLESONIDE
Active Ingredient Strength50 ug/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 63402-701-02

1 POUCH in 1 CARTON (63402-701-02) > 1 BOTTLE, SPRAY in 1 POUCH > 60 SPRAY in 1 BOTTLE, SPRAY
Marketing Start Date2008-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63402-701-02 [63402070102]

Omnaris SPRAY
Marketing CategoryNDA
Application NumberNDA022004
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-03-01
Marketing End Date2019-12-01

NDC 63402-701-01 [63402070101]

Omnaris SPRAY
Marketing CategoryNDA
Application NumberNDA022004
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2008-03-01
Marketing End Date2019-12-01

Drug Details

Medicade Reported Pricing

63402070101 OMNARIS 50 MCG NASAL SPRAY

Pricing Unit: GM | Drug Type:

NDC Crossover Matching brand name "Omnaris" or generic name "Ciclesonide"

NDCBrand NameGeneric Name
63402-701Omnarisciclesonide
70515-701Omnarisciclesonide
63402-711Alvescociclesonide
63402-712Alvescociclesonide
70515-711Alvescociclesonide
70515-712Alvescociclesonide
66993-015Ciclesonideciclesonide
66993-571Ciclesonideciclesonide
66993-572Ciclesonideciclesonide
63402-737Zetonnaciclesonide
70515-737Zetonnaciclesonide

Trademark Results [Omnaris]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OMNARIS
OMNARIS
78949782 3574160 Live/Registered
Altana Pharma AG
2006-08-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.