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Ciprofloxacin

Ciprofloxacin Ophthalmic Solution, USP 0.3%

Approved
Approval ID

0d6b023f-6296-4567-b0f0-819eaefbfdc5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 10, 2018

Manufacturers
FDA

Unit Dose Services

DUNS: 831995316

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ciprofloxacin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50436-0714
Application NumberANDA076555
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 11, 2011
FDA Product Classification

INGREDIENTS (9)

sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 3 mg in 1 mL
Code: 4BA73M5E37
Classification: ACTIM
benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT

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Ciprofloxacin - FDA Drug Approval Details