NASONEX

Basic Information

Product Name

NASONEX

FDA Product Code

54868-4174

Regulatory Information

NDC Product Code

54868-4174

Application Number

NDA020762

Marketing Category

C73594

Effective Date

April 27, 2011

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use NASONEX safely and effectively. See full prescribing information for NASONEX. NASONEX (mometasone furoate monohydrate) Nasal Spray 50 mcg calculated on the anhydrous basis Initial U.S. Approval: 1997

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MOMETASONE FUROATE

Quantity: 50 ug in 1 1

Code: 04201GDN4R

Class Code: ACTIB

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CARBOXYMETHYLCELLULOSE SODIUM

Code: K679OBS311

Class Code: IACT

SODIUM CITRATE

Code: 1Q73Q2JULR

Class Code: IACT

CITRIC ACID MONOHYDRATE

Code: 2968PHW8QP

Class Code: IACT

BENZALKONIUM CHLORIDE

Code: F5UM2KM3W7

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

Active Moieties

MOMETASONE

Code: 8HR4QJ6DW8

Basic Information

Regulatory Information

Company Information

Active Ingredients

GLYCERIN

CELLULOSE, MICROCRYSTALLINE

CARBOXYMETHYLCELLULOSE SODIUM

SODIUM CITRATE

CITRIC ACID MONOHYDRATE

BENZALKONIUM CHLORIDE

POLYSORBATE 80

Active Moieties

MOMETASONE