Ciprofloxacin and Dexamethasone

Basic Information

Product Name

FDA Product Code

53746-831

Regulatory Information

NDC Product Code

53746-831

Application Number

ANDA216501

Marketing Category

C73584

Effective Date

March 26, 2024

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION safely and effectively. See full prescribing information for CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION. CIPROFLOXACIN AND DEXAMETHASONE otic suspension Initial U.S. Approval: 2003

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

DEXAMETHASONE

Quantity: 1 mg in 1 mL

Code: 7S5I7G3JQL

Class Code: ACTIB

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

CIPROFLOXACIN HYDROCHLORIDE

Quantity: 3 mg in 1 mL

Code: 4BA73M5E37

Class Code: ACTIM

BENZALKONIUM CHLORIDE

Code: F5UM2KM3W7

Class Code: IACT

BORIC ACID

Code: R57ZHV85D4

Class Code: IACT

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)

Code: R33S7TK2EP

Class Code: IACT

SODIUM ACETATE

Code: 4550K0SC9B

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

TYLOXAPOL

Code: Y27PUL9H56

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

CIPROFLOXACIN

Code: 5E8K9I0O4U

DEXAMETHASONE

Code: 7S5I7G3JQL

Basic Information

Regulatory Information

Company Information

Active Ingredients

ACETIC ACID

BENZALKONIUM CHLORIDE

BORIC ACID

EDETATE DISODIUM

HYDROCHLORIC ACID

HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)

SODIUM ACETATE

SODIUM CHLORIDE

TYLOXAPOL

SODIUM HYDROXIDE

WATER

Active Moieties

CIPROFLOXACIN

DEXAMETHASONE