MOMETASONE FUROATE MONOHYDRATE

Basic Information

Product Name

FDA Product Code

59651-402

Regulatory Information

NDC Product Code

59651-402

Application Number

ANDA215878

Marketing Category

C73584

Effective Date

March 22, 2024

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use MOMETASONE FUROATE MONOHYDRATE NASAL SPRAY safely and effectively. See full prescribing information for MOMETASONE FUROATE MONOHYDRATE NASAL SPRAY. MOMETASONE FUROATE MONOHYDRATE nasal spray Initial U.S. Approval: 1997

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

MOMETASONE FUROATE MONOHYDRATE

Quantity: 50 ug in 1 1

Code: MTW0WEG809

Class Code: ACTIR

BENZALKONIUM CHLORIDE

Code: F5UM2KM3W7

Class Code: IACT

CITRIC ACID MONOHYDRATE

Code: 2968PHW8QP

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED

Code: K679OBS311

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

TRISODIUM CITRATE DIHYDRATE

Code: B22547B95K

Class Code: IACT

Active Moieties

MOMETASONE

Code: 8HR4QJ6DW8

Basic Information

Regulatory Information

Company Information

Active Ingredients

BENZALKONIUM CHLORIDE

CITRIC ACID MONOHYDRATE

GLYCERIN

MICROCRYSTALLINE CELLULOSE

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED

POLYSORBATE 80

WATER

TRISODIUM CITRATE DIHYDRATE

Active Moieties

MOMETASONE