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NDC 53002-1320-01 Ciprofloxacin 3.5 mg/mL Details

Ciprofloxacin 3.5 mg/mL

Ciprofloxacin is a TOPICAL SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is CIPROFLOXACIN HYDROCHLORIDE.

MedlinePlus Drug Summary

Ciprofloxacin ophthalmic solution is used to treat bacterial infections of the eye including conjunctivitis (pinkeye; infection of the membrane that covers the outside of the eyeball and the inside of the eyelid) and corneal ulcers (infection and loss of tissue in the clear front part of the eye). Ciprofloxacin ophthalmic ointment is used to treat conjunctivitis. Ciprofloxacin is in a class of antibiotics called fluoroquinolones. It works by killing the bacteria that cause infection.

Related Packages: 53002-1320-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ciprofloxacin Ophthalmic

Product Information

NDC	53002-1320
Product ID	53002-1320_59900837-7961-4866-b678-5af4d6fc6c7a
Associated GPIs	86101023102010
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Ciprofloxacin
Proprietary Name Suffix	n/a
Non-Proprietary Name	CIPROFLOXACIN HYDROCHLORIDE
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SOLUTION/ DROPS
Route	TOPICAL
Active Ingredient Strength	3.5
Active Ingredient Units	mg/mL
Substance Name	CIPROFLOXACIN HYDROCHLORIDE
Labeler Name	RPK Pharmaceuticals, Inc.
Pharmaceutical Class	Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA077689
Listing Certified Through	2024-12-31

Package

NDC 53002-1320-01 (53002132001)

Pricing Information	N/A
NDC Package Code	53002-1320-1
Billing NDC	53002132001
Package	2.5 mL in 1 BOTTLE, DROPPER (53002-1320-1)
Marketing Start Date	2017-09-01
NDC Exclude Flag	N