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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0744342f-aac4-801e-ee21-395ccd0c8e83Product name120140508
85b616d1-2593-be25-fa48-8e59fa292b7bProduct name120140508
c2c67206-646a-760e-80fc-8113bd89fd45Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63402-701-01GM - Gram63402-701f4162c5a-4074-4f08-857f-54da3773729312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CICLESONIDEACTIVE INGREDIENTS59502J185OMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.]1
CICLESONIDEACTIVE MOIETYS59502J185OMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311OMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUOMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOOMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4OMNARIS (CICLESONIDE) SPRAY [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797841ciclesonide 50 MCG/ACTUAT Metered Dose Nasal SprayPSN45e1c9d9-b8bc-4df9-acbb-d3a9c31a24b01
1797843omnaris 50 MCG/ACTUAT Metered Dose Nasal SprayPSN45e1c9d9-b8bc-4df9-acbb-d3a9c31a24b01
1797843ciclesonide 0.05 MG/ACTUAT Metered Dose Nasal Spray [Omnaris]SBD45e1c9d9-b8bc-4df9-acbb-d3a9c31a24b01
1797841ciclesonide 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD45e1c9d9-b8bc-4df9-acbb-d3a9c31a24b01
1797841ciclesonide 50 MCG/ACTUAT Metered Dose Nasal SpraySY45e1c9d9-b8bc-4df9-acbb-d3a9c31a24b01
1797843Omnaris 0.05 MG/ACTUAT Metered Dose Nasal SpraySY45e1c9d9-b8bc-4df9-acbb-d3a9c31a24b01
1797843omnaris 50 MCG/ACTUAT Metered Dose Nasal SpraySY45e1c9d9-b8bc-4df9-acbb-d3a9c31a24b01