NASONEX
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
Approved
Approval ID
a06f66a9-ca36-48c6-a00d-4f614b539cdf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mometasone furoate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4174
Application NumberNDA020762
Product Classification
M
Marketing Category
C73594
G
Generic Name
mometasone furoate
Product Specifications
Route of AdministrationNASAL
Effective DateApril 27, 2011
FDA Product Classification
INGREDIENTS (8)
MOMETASONE FUROATEActive
Quantity: 50 ug in 1 1
Code: 04201GDN4R
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT