FDA Product

ciprofloxacin

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

ciprofloxacin

FDA Product Code

50090-4217

Regulatory Information

NDC Product Code

50090-4217

Application Number

ANDA077568

Marketing Category

C73584

Effective Date

April 26, 2020

Territorial Authority

USA

FDA Title

Ciprofloxacin ophthalmic solution USP0.3% Sterile

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

6

Company Information

ManufacturerA-S Medication Solutions

DUNS Number

830016429

Active Ingredients

SODIUM ACETATE ANHYDROUS

Code: NVG71ZZ7P0

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

BENZALKONIUM CHLORIDE

Code: F5UM2KM3W7

Class Code: IACT

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

CIPROFLOXACIN HYDROCHLORIDE

Quantity: 3 mg in 1 mL

Code: 4BA73M5E37

Class Code: ACTIM

Active Moieties

CIPROFLOXACIN

Code: 5E8K9I0O4U

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