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(from DailyMed)

CIPROFLOXACIN 500 mg Tablet, Film Coated, 20-count

by DirectRx · 20 TABLET, FILM COATED in 1 BOTTLE (72189-300-20)

NDC 72189-0300-20

🏷️ FDA NDC (as labeled) 72189-300-20 billing pads the product segment with a zero

This package

Contains20-count Pack sizes2 compare ↓

Also priced by: Part D plans $0.2764/unit — full pricing hub ↓

Also comes in: 6 tablets 72189-0300-06

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Other active recalls for Ciprofloxacin (different manufacturers) — 3 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Mar 11, 2025 — Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle (FDC Limited) · FDA recall D-0282-2025

Class II · Dec 16, 2024 — Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle (FDC Limited) · FDA recall D-0182-2025

Class II · Jul 23, 2024 — Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. (FDC Limited) · FDA recall D-0623-2024

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 72189-300-20

Product NDC 72189-300

11-digit billing NDC 72189030020

RxCUI 309309

UNII 4BA73M5E37

Application # ANDA076558

SPL Set ID d23e359d-6d12-38f6-e053-2a95a90a0a88

Established class (EPC) Fluoroquinolone Antibacterial

Mechanism of action Cytochrome P450 1A2 Inhibitors

Chemical class Fluoroquinolones

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2021-12-03

Route ORAL

Dosage form TABLET, FILM COATED

Substance CIPROFLOXACIN HYDROCHLORIDE

GPI-14 05000020100315

GPI class Ciprofloxacin HCl

GCN Seq No 009510

GCN 47051

HICL code 004124

Ingredient (HICL) Ciprofloxacin Hcl

HIC1 code W

Therapeutic class — broad (HIC1) Anti-Infecting Agents

HIC2 code W1

Therapeutic class — intermediate (HIC2) Antibiotics

HIC3 code W1Q

Therapeutic class — specific (HIC3) Quinolone Antibiotics

AHFS code 08:12.18.00

AHFS class Quinolone Antibiotics

FDB label name CIPROFLOXACIN HCL 500 MG TAB

FDB brand name Ciprofloxacin Hcl

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 72189-300-20 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72189-0300-20. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Fluoroquinolone Antibacterial class.

Pharmacologic class Fluoroquinolone Antibacterial

Drug family (ATC) Fluoroquinolones, Fluoroquinolones, Antiinfectives

How it works Cytochrome P450 1A2 Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerDirectRx

Application holderHIKMA PHARMACEUTICALS

FDA applicationANDA076558 (ANDA)

Labeler code72189

First marketedDec 2021

Product typeHuman Prescription Drug

Portfolio49 products on file

🔎 All NDCs from DirectRx

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CIPROFLOXACIN HCL 500 MG TAB Ingredient Ciprofloxacin Hcl

📗 Our plain-language guide HelloPharmacist

Ciprofloxacin treats a wide range of bacterial infections — things like urinary tract infections, skin infections, bone and joint infections, infectious diarrhea, typhoid fever, an...
What kinds of infections does ciprofloxacin actually treat?
You can take ciprofloxacin with or without food — that part's flexible. But avoid taking it at the same time as milk, yogurt, or calcium-fortified juices, because dairy and calcium...
The most common side effects are nausea, diarrhea, and vomiting — uncomfortable, but usually manageable. The ones that mean stop-and-call-your-doctor-now are tendon pain (especiall...

📖 Read our full Ciprofloxacin guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Ciprofloxacin — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Ciprofloxacin (163 interactions) — ranked by severity →

Nutrient depletion considerations

Ciprofloxacin may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.

BIOTIN Insignificant Depletion CALCIUM Insignificant Depletion FOLIC ACID Insignificant Depletion IRON Insignificant Depletion MAGNESIUM Insignificant Depletion +6 more

🧪 Full Ciprofloxacin nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 8470G57WFM
Corn oil is a vegetable oil extracted from corn kernels. It's used in medicines as a solvent to dissolve active ingredients and help the body absorb them, and sometimes as a lubricant in capsules.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$0.2764	$5.53 / 20 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ciprofloxacin 500 mg 00143-9928-01	Hikma	100 tablets	$0.124	—	Availability likely	—
ciprofloxacin 500 mg 00904-7243-61	Major	100 tablets	$0.124	AB	Availability likely	—
Ciprofloxacin 500 mg 16252-0515-01	Teva	100 tablets	$0.124	AB	Availability likely	—
Ciprofloxacin 500 mg 43547-0689-10	Solco	100 tablets	$0.124	AB	Availability likely	—
Ciprofloxacin 500 mg 59651-0867-01	Aurobindo	100 tablets	$0.124	AB	Availability likely	—
Ciprofloxacin 500 mg 60687-0860-01	American	1 tablet	$0.124	AB	Availability likely	—
Ciprofloxacin 500 mg 60687-0947-01	American	1 tablet	$0.124	AB	Availability likely	—
Ciprofloxacin 500 mg 61442-0223-01	Carlsbad	100 tablets	$0.124	AB	Availability likely	—
Ciprofloxacin 500 mg 62135-0309-01	Chartwell	100 tablets	$0.124	AB	Availability likely	—
Ciprofloxacin 500 mg 65862-0077-01	Aurobindo	100 tablets	$0.124	AB	Availability likely	—
Ciprofloxacin Hydrochloride 500 mg 69367-0386-01	Westminster	100 tablets	$0.124	AB	Availability likely	—
Ciprofloxacin 500 mg 58657-0676-01	Method	100 tablets	$0.159	AB	FDA listed	—
Ciprofloxacin 500 mg 00615-8546-10	NCS	10 tablets	—	AB	Discontinued	—
Ciprofloxacin 500 mg 00615-8630-10	NCS	10 tablets	—	AB	FDA listed	—
ciprofloxacin 500 mg 16571-0412-05	Rising	50 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 42708-0088-14	QPharma	14 tablets	—	AB	FDA listed	—
ciprofloxacin 500 mg 42708-0192-14	QPharma,	14 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 43063-0547-01	PD-Rx	100 tablets	—	AB	FDA listed	—
ciprofloxacin 500 mg 43063-0869-06	PD-Rx	6 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 43063-0923-02	PD-Rx	2 tablets	—	AB	FDA listed	—
ciprofloxacin 500 mg 50090-1648-00	A-S	20 tablets	—	AB	FDA listed	—
ciprofloxacin 500 mg 50090-1649-00	A-S	20 tablets	—	AB	FDA listed	—
Ciprofloxacin Hydrochloride 500 mg 50090-7843-00	A-S	20 tablets	—	AB	FDA listed	—
Ciprofloxacin Hydrochloride 500 mg 50090-7848-01	A-S	14 tablets	—	AB	FDA listed	—
Cipro 500 mg 50419-0754-01	Bayer	100 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 51407-0165-01	Golden	100 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 51655-0216-20	Northwind	20 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 51655-0490-20	Northwind	20 tablets	—	AB	FDA listed	—
ciprofloxacin 500 mg 54348-0663-01	PharmPak,	1 tablet	—	AB	FDA listed	—
ciprofloxacin 500 mg 55154-0193-00	Cardinal	1 tablet	—	AB	FDA listed	—
Ciprofloxacin 500 mg 59651-0977-15	Aurobindo	1500 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 60429-0042-20	Golden	20 tablets	—	—	FDA listed	—
Ciprofloxacin 500 mg 60760-0676-10	St.	10 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 60760-0689-10	ST.	10 tablets	—	AB	FDA listed	—
ciprofloxacin 500 mg 63187-0017-06	Proficient	6 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 63629-1010-01	Bryant	100 tablets	—	AB	FDA listed	—
ciprofloxacin 500 mg 66267-0716-02	NuCare	2 tablets	—	AB	FDA listed	—
ciprofloxacin 500 mg 66267-0919-06	NuCare	6 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 67046-1537-03	Coupler	30 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 67296-1848-02	Redpharm	20 tablets	—	AB	Discontinued	—
Ciprofloxacin 500 mg 67296-2135-01	Redpharm	14 tablets	—	AB	FDA listed	—
Ciprofloxacin Hydrochloride 500 mg 67296-2208-01	Redpharm	10 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 68071-2267-01	NuCare	10 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 68071-2269-04	NuCare	4 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 68071-2384-01	NuCare	10 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 68071-2404-02	NuCare	2 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 68071-3610-01	NuCare	10 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 68071-3737-02	NuCare	2 tablets	—	AB	FDA listed	—
ciprofloxacin 500 mg 68071-4122-01	NuCare	10 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 68788-8136-00	Preferred	6 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 68788-8692-00	Preferred	6 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 69117-0009-01	Yiling	500 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 69238-2433-01	Amneal	100 tablets	—	—	FDA listed	—
Ciprofloxacin 500 mg 70518-3063-00	REMEDYREPACK	30 tablets	—	—	Discontinued	—
Ciprofloxacin 500 mg 70518-4214-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 70518-4229-00	REMEDYREPACK	14 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 70934-0965-06	Denton	6 tablets	—	AB	Discontinued	—
Ciprofloxacin 500 mg 71205-0649-06	Proficient	6 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 71205-0997-00	Proficient	100 tablets	—	AB	FDA listed	—
ciprofloxacin 500 mg 71335-0070-00	Bryant	7 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 71335-1229-00	Bryant	7 tablets	—	AB	Discontinued	—
Ciprofloxacin 500 mg 71335-1347-00	Bryant	7 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 71335-2046-00	Bryant	7 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 71335-2054-00	Bryant	7 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 71335-2450-00	Bryant	7 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 71610-0081-83	Aphena	3600 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 71610-0109-30	Aphena	30 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 71610-0159-83	Aphena	3600 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 72162-1741-02	Bryant	14 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 72162-2425-01	Bryant	100 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 72189-0111-14	DIRECT	14 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mgthis 72189-0300-20	DirectRx	20 tablets	—	—	FDA listed	—
Ciprofloxacin 500 mg 72189-0623-10	Direct_Rx	10 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 72189-0627-10	Direct_Rx	10 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 72789-0065-20	PD-Rx	20 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 72789-0108-02	PD-Rx	2 tablets	—	—	FDA listed	—
Ciprofloxacin 500 mg 72789-0118-01	PD-Rx	100 tablets	—	—	FDA listed	—
Ciprofloxacin 500 mg 72789-0330-06	PD-Rx	6 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 72789-0511-10	PD-Rx	10 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 72789-0520-06	PD-Rx	6 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 76420-0045-06	Asclemed	6 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 76420-0929-01	Asclemed	100 tablets	—	AB	FDA listed	—
Ciprofloxacin HCL 500 mg 80425-0192-01	Advanced	20 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 80425-0492-01	Advanced	20 tablets	—	AB	FDA listed	—
Ciprofloxacin Hydrochloride 500 mg 80425-0493-01	Advanced	20 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 82804-0130-06	Proficient	6 tablets	—	AB	FDA listed	—
Ciprofloxacin Hydrochloride 500 mg 82804-0260-06	Proficient	6 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 82982-0050-14	Pharmasource	14 tablets	—	AB	Discontinued	—
Ciprofloxacin 500 mg 83008-0078-20	Quality	20 tablets	—	AB	Discontinued	—
Ciprofloxacin Hydrochloride 500 mg 83939-0002-01	VERITYRX,	1 tablet	—	AB	FDA listed	—
ciprofloxacin 500 mg 85293-0003-01	Umasuto,	100 tablets	—	AB	FDA listed	—
Ciprofloxacin 500 mg 85766-0100-01	Sportpharm	100 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2021

On the market since

Dec 2021

📍

2026

Currently FDA-listed

5 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Cipro (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cipro. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$92.9K

Claims incl. refills

550

Beneficiaries

474

Spend / beneficiary

$196.00

Spend / claim

$168.91

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
72189-0300-06	6 TABLET, FILM COATED in 1 BOTTLE (72189-300-06)	2021-12-03	Active
72189-0300-20 You're viewing this	20 TABLET, FILM COATED in 1 BOTTLE (72189-300-20)	2021-12-03	Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 72189-0300-20?

NDC 72189-0300-20 is a 20-count package — 20 tablet, film coated in 1 bottle.

What is the difference between NDC 72189-0300-20 and NDC 72189-0300-06?

Both are CIPROFLOXACIN 500 mg Tablet, Film Coated — the drug itself is identical. NDC 72189-0300-20 is the 20-count package, while NDC 72189-0300-06 is the 6 tablets package.

What NDC number is used to bill for this package of CIPROFLOXACIN 500 mg Tablet, Film Coated?

Bill NDC 72189-0300-20 — the 11-digit billing format is 72189030020. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 72189-300-20, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72189-0300-20, written without dashes as 72189030020. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 72189-0300-20, the first segment (72189) is the labeler code FDA assigned to DirectRx; the middle segment (0300) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by DirectRx. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 6 tablets (72189-0300-06). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

DirectRx is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide

🎯 Indications and Usage ~2 min read ▾

1.1Skin and Skin Structure Infections Ciprofloxacin tablets are indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.

1.2Bone and Joint Infections Ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

1.3Complicated Intra-Abdominal Infections Ciprofloxacin tablets are indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

1.4Infectious Diarrhea Ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii †, Shigella dysenteriae, Shigella flexneri or Shigella sonnei† when antibacterial therapy is indicated. †Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.

1.5Typhoid Fever (Enteric Fever) Ciprofloxacin tablets are indicated in adult patients for treatment of typhoid fever (enteric fever) caused by Salmonella typhi. The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.

1.6Uncomplicated Cervical and Urethral Gonorrhea Ciprofloxacin tablets are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae [see WARNINGS AND PRECAUTIONS (5.17)].

1.7Inhalational Anthrax (Post-Exposure) Ciprofloxacin tablets are indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.1 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001 [see CLINICAL STUDIES (14.2)].

1.8Plague Ciprofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see CLINICAL STUDIES (14.3)].

1.9Chronic Bacterial Prostatitis Ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.

1.10Lower Respiratory Tract Infections Ciprofloxacin tablets are indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae. Ciprofloxacin tablets are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae. Ciprofloxacin tablets are indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by Moraxella catarrhalis.

Because fluoroquinolones, including ciprofloxacin tablets, have been associated w…

⏱️ Dosage and Administration ~3 min read ▾

Ciprofloxacin tablets should be administered orally as described in the appropriate Dosage Guidelines tables.

2.1Dosage in Adults The determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function. Ciprofloxacin tablets may be administered to adult patients when clinically indicated at the discretion of the physician. Table 1: Adult Dosage Guidelines Infection Dose Frequency Usual Durations1 Skin and Skin Structure 500-750 mg every 12 hours 7 to 14 days Bone and Joint 500-750 mg every 12 hours 4 to 8 weeks Complicated Intra-Abdominal2 500 mg every 12 hours 7 to 14 days Infectious Diarrhea 500 mg every 12 hours 5 to 7 days Typhoid Fever 500 mg every 12 hours 10 days Uncomplicated Urethral and Cervical Gonococcal Infections 250 mg single dose single dose Inhalational anthrax (post-exposure)3 500 mg every 12 hours 60 days Plague3 500-750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract Infections 500-750 mg every 12 hours 7 to 14 days Urinary Tract Infections 250-500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Acute Sinusitis 500 mg every 12 hours 10 days 1.

Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). 2. Used in conjunction with metronidazole.

3. Begin drug administration as soon as possible after suspected or confirmed exposure. Conversion of IV to Oral Dosing in Adults Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (Table 2) [see CLINICAL PHARMACOLOGY (12.3)].

Table 2: Equivalent AUC Dosing Regimens Ciprofloxacin Tablets Oral Dosage Equivalent Ciprofloxacin IV Dosage 250 mg Tablet every 12 hours 200 mg intravenous every 12 hours 500 mg Tablet every 12 hours 400 mg intravenous every 12 hours 750 mg Tablet every 12 hours 400 mg intravenous every 8 hours

2.2Dosage in Pediatric Patients Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin tablets should be administered as described in Table 3. Table 3: Pediatric Dosage Guidelines Infection Dose Frequency Total Duration Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg) Every 12 hours 10–21 days1 Inhalational Anthrax (Post-Exposure)2 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 days Plague2,3 15 mg/kg (maximum 500 mg per dose) Every 8 to 12 hours 14 days 1.

The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). 2.

Begin drug administration as soon as possible after suspected or confirmed exposure. 3. Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.

2.3Dosage Modifications in Patients with Renal Impairment Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction.

Dosage guidelines for use in patients with renal impairment are shown in Table 4. Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal Functio…

💊 Dosage Forms and Strengths 46 words ▾

3.1Tablets 250 mg white, round, film-coated tablets imprinted with "WW927" on one side. 500 mg white medium capsule shape, film-coated tablet, engraved with "WW928" from one side and plain from the other side. 750 mg white, large capsule-shaped, film-coated tablets imprinted with "WW929" on one

⛔ Contraindications 34 words ▾

4.1Hypersensitivity Ciprofloxacin tablets are contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components [see WARNINGS AND PRECAUTIONS (5.7)].

⚠️ Warnings and Cautions ~2 min read ▾

5.1Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including ciprofloxacin tablets, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion).

These reactions can occur within hours to weeks after starting ciprofloxacin tablets. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see WARNINGS AND PRECAUTIONS (5.2, 5.3, 5.4)]. Discontinue ciprofloxacin tablets immediately at the first signs or symptoms of any serious adverse reaction.

In addition, avoid the use of fluoroquinolones, including ciprofloxacin tablets, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

5.2Tendinitis and Tendon Rupture Fluoroquinolones, including ciprofloxacin tablets, have been associated with an increased risk of tendinitis and tendon rupture in all ages [see WARNINGS AND PRECAUTIONS (5.1) and ADVERSE REACTIONS (6.2)]. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur, within hours or days of starting ciprofloxacin tablets, or as long as several months after completion of fluoroquinolone therapy.

Tendinitis and tendon rupture can occur bilaterally. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.

Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Discontinue ciprofloxacin tablets immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including ciprofloxacin tablets, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture [see ADVERSE REACTIONS (6.2)].

5.3Peripheral Neuropathy Fluoroquinolones, including ciprofloxacin tablets, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including ciprofloxacin tablets. Symptoms may occur soon after initiation of ciprofloxacin tablets and may be irreversible in some patients [see WARNINGS AND PRECAUTIONS (5.1) and ADVERSE REACTIONS (6.1, 6.2)].

Discontinue ciprofloxacin tablets immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations including light touch, pain, temperature, position sense and vibratory sensation, and/or motor strength in order to minimize the development of an irreversible condition. Avoid fluoroquinolones, including ciprofloxacin tablets, in patients who have previously experienced peripheral neuropathy [see ADVERSE REACTIONS (6.1, 6.2)].

5.4Central Nervous System Effects Psychiatric Adverse Reactions Fluoroquinolones, including ciprofloxacin tablets have been associated with an increased risk of psychiatric adverse reactions, including: toxic psychosis, psychotic reactions progressing t…

🤒 Adverse Reactions ~2 min read ▾

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Disabling and Potentially Irreversible Serious Adverse Reactions [see WARNINGS AND PRECAUTIONS (5.1)] Tendinitis and Tendon Rupture [see WARNINGS AND PRECAUTIONS (5.2)] Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS (5.3)] Central Nervous System Effects [see WARNINGS AND PRECAUTIONS (5.4)] Exacerbation of Myasthenia Gravis [see WARNINGS AND PRECAUTIONS (5.5)] Other Serious and Sometimes Fatal Adverse Reactions [see WARNINGS AND PRECAUTIONS (5.6)] Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS (5.7)] Hepatotoxicity [see WARNINGS AND PRECAUTIONS (5.8)] Risk of Aortic Aneurysm and Dissection [see WARNINGS AND PRECAUTIONS (5.9)] Serious Adverse Reactions with Concomitant Theophylline [see WARNINGS AND PRECAUTIONS (5.10)] Clostridioides difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS (5.11)] Prolongation of the QT Interval [see WARNINGS AND PRECAUTIONS (5.12)] Musculoskeletal Disorders in Pediatric Patients [see WARNINGS AND PRECAUTIONS (5.13)] Photosensitivity/Phototoxicity [see WARNINGS AND PRECAUTIONS (5.14)] Development of Drug Resistant Bacteria [see WARNINGS AND PRECAUTIONS (5.15)]

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Patients During clinical investigations with oral and parenteral ciprofloxacin, 49,038 patients received courses of the drug. The most frequently reported adverse reactions, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications of ciprofloxacin therapy were nausea (2.5%), diarrhea (1.6%), liver function tests abnormal (1.3%), vomiting (1%), and rash (1%).

Table 8: Medically Important Adverse Reactions That Occurred in less than 1% of Ciprofloxacin Patients System Organ Class Adverse Reactions Body as a Whole Headache Abdominal Pain/Discomfort Pain Cardiovascular Syncope Angina Pectoris Myocardial Infarction Cardiopulmonary Arrest Tachycardia Hypotension Central Nervous System Restlessness Dizziness Insomnia Nightmares Hallucinations Paranoia Psychosis (toxic) Manic Reaction Irritability Tremor Ataxia Seizures (including Status Epilepticus) Malaise Anorexia Phobia Depersonalization Depression (potentially culminating in self-injurious behavior (such as suicidal ideations/thoughts and attempted or completed suicide) Paresthesia Abnormal Gait Migraine Gastrointestinal Intestinal Perforation Gastrointestinal Bleeding Cholestatic Jaundice Hepatitis Pancreatitis Hemic/Lymphatic Petechia Metabolic/Nutritional Hyperglycemia Hypoglycemia Musculoskeletal Arthralgia Joint Stiffness Muscle Weakness Renal/Urogenital Interstitial Nephritis Renal Failure Respiratory Dyspnea Laryngeal Edema Hemoptysis Bronchospasm Skin/Hypersensitivity Anaphylactic Reactions including life-threatening anaphylactic shock Erythema Multiforme/Stevens-Johnson Syndrome Exfoliative Dermatitis Toxic Epidermal Necrolysis Pruritus Urticaria Photosensitivity/Phototoxicity reaction Flushing Fever Angioedema Erythema Nodosum Sweating Special Senses Blurred Vision Disturbed Vision (chromatopsia and photopsia) Decreased Visual Acuity Diplopia Tinnitus Hearing Loss Bad Taste In randomized, double-blind controlled clinical trials comparing ciprofloxacin tablets [500 mg two times daily (BID)] to cefuroxime axetil (250 mg–500 mg BID) and to clarithromycin (500 mg BID) in patients with respiratory tract infections, ciprofloxacin tablets demonstrated a CNS adverse reaction profile comparable to the control drugs.

Pediatric Patients Short (6 weeks) and long term (1 year) musculoskeletal and neurological safety of oral/intravenous ciprofloxacin, was compared to a cephalosporin for treatment of cUTI…

🔄 Drug Interactions ~2 min read ▾

Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Co-administration of ciprofloxacin tablets with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the co-administered drug. Table 11: Drugs That are Affected by and Affecting Ciprofloxacin Tablets Drugs That are Affected by Ciprofloxacin Tablets Drug(s) Recommendation Comments Tizanidine Contraindicated Concomitant administration of tizanidine and ciprofloxacin tablets is contraindicated due to the potentiation of hypotensive and sedative effects of tizanidine [see Contraindications (4.2)] every 12 hours Theophylline Avoid Use (Plasma Exposure Likely to be Increased and Prolonged) Concurrent administration of ciprofloxacin tablets with theophylline may result in increased risk of a patient developing central nervous system (CNS) or other adverse reactions.

If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate [see Warnings and Precautions (5.10)]. Drugs Known to Prolong QT Interval Avoid Use Ciprofloxacin tablets may further prolong the QT interval in patients receiving drugs known to prolong the QT interval (for example, class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) [see Warnings and Precautions (5.12) and Use in Specific Populations (8.5)]. Oral antidiabetic drugs Use with caution Glucose-lowering effect potentiated Hypoglycemia sometimes severe has been reported when ciprofloxacin tablets and oral antidiabetic agents, mainly sulfonylureas (for example, glyburide, glimepiride), were co-administered, presumably by intensifying the action of the oral antidiabetic agent.

Fatalities have been reported. Monitor blood glucose when ciprofloxacin tablets are co-administered with oral antidiabetic drugs [see Adverse Reactions (6.1)]. Phenytoin Use with caution Altered serum levels of phenytoin (increased and decreased) To avoid the loss of seizure control associated with decreased phenytoin levels and to prevent phenytoin overdose-related adverse reactions upon ciprofloxacin tablets discontinuation in patients receiving both agents, monitor phenytoin therapy, including phenytoin serum concentration during and shortly after co-administration of ciprofloxacin tablets with phenytoin.

Cyclosporine Use with caution (transient elevations in serum creatinine) Monitor renal function (in particular serum creatinine) when ciprofloxacin tablets is co-administered with cyclosporine. Anti-coagulant drugs Use with caution (Increase in anticoagulant effect) The risk may vary with the underlying infection, age and general status of the patient so that the contribution of ciprofloxacin tablets to the increase in INR (international normalized ratio) is difficult to assess. Monitor prothrombin time and INR frequently during and shortly after co-administration of ciprofloxacin tablets with an oral anti-coagulant (for example, warfarin).

Methotrexate Use with caution Inhibition of methotrexate renal tubular transport potentially leading to increased methotrexate plasma levels Potential increase in the risk of methotrexate associated toxic reactions. Therefore, carefully monitor patients under methotrexate therapy when concomitant ciprofloxacin tablets therapy is indicated. Ropinirole Use with caution Monitoring for ropinirole-related adverse reactions and appropriate dose adjustment of ropinirole is recommended during and shortly after co-administration with ciprofloxacin tablets [see Warnings and Precautions (5.16)].

Clozapine Use with caution Careful monitoring of clozapine associated adverse reactions and appropriate adjustment of clozapine dosage during and shortly after co-administration with ciprofloxacin tablets are advised. NSAIDs Use with caution Non-steroidal anti-inflammatory drugs (but not acetyl salicylic acid) in combination of very high doses of qui…

👥 Use in Specific Populations ~3 min read ▾

8.1Pregnancy Risk Summary Prolonged experience with ciprofloxacin in pregnant women over several decades, based on available published information from case reports, case control studies and observational studies on ciprofloxacin administered during pregnancy, have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data). Oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits did not cause fetal malformations (see Data).

These doses were up to 0.3, 0.6, and 0.4 times the maximum recommended clinical oral dose in mice, rats, and rabbits, respectively, based on body surface area. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective observational studies over several decades have not established an association with ciprofloxacin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available studies have methodological limitations including small sample size and some of them are not specific for ciprofloxacin.

A controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to ciprofloxacin and 68% first trimester exposures) during gestation. In utero exposure to fluoroquinolones during embryogenesis was not associated with increased risk of major malformations. The reported rates of major congenital malformations were 2.2% for the fluoroquinolone group and 2.6% for the control group (background incidence of major malformations is 1–5%).

Rates of spontaneous abortions, prematurity and low birth weight did not differ between the groups and there were no clinically significant musculoskeletal dysfunctions up to one year of age in the ciprofloxacin exposed children. Another prospective follow-up study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures). There were 70 ciprofloxacin exposures, all within the first trimester.

The malformation rates among live-born babies exposed to ciprofloxacin and to fluoroquinolones overall were both within background incidence ranges. No specific patterns of congenital abnormalities were found. The study did not reveal any clear adverse reactions due to in utero exposure to ciprofloxacin.

No differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to ciprofloxacin during pregnancy. However, these small postmarketing epidemiology studies, of which most experience is from short term, first trimester exposure, are insufficient to evaluate the risk for less common defects or to permit reliable and definitive conclusions regarding the safety of ciprofloxacin in pregnant women and their developing fetuses. Animal Data Developmental toxicology studies have been performed with ciprofloxacin in rats, mice, and rabbits.

In rats and mice, oral doses up to 100 mg/kg administered during organogenesis (Gestation Days, GD, 6-17) were not associated with adverse developmental outcomes, including embryofetal toxicity or malformations. In rats and mice, a 100 mg/kg dose is approximately 0.6 and 0.3 times the maximum daily human oral dose (1500 mg/day) based upon body surface area, respectively. In a series of rabbit developmental toxicology studies, does received oral or intravenous ciprofloxacin for one of the following 5 day periods: GD 6 to 10, GD 10 to 14, or GD 14 to 18, intended to cover the period of organogenesis.

This was an attempt to m…

🆘 Overdosage 87 words ▾

In the event of acute overdosage, reversible renal toxicity has been reported in some cases. Empty the stomach by inducing vomiting or by gastric lavage. Observe the patient carefully and give supportive treatment, including monitoring of renal function, urinary pH and acidify, if required, to prevent crystalluria and administration of magnesium, aluminum, or calcium containing antacids which can reduce the absorption of ciprofloxacin.

Adequate hydration must be maintained. Only a small amount of ciprofloxacin (less than 10%) is removed from the body after hemodialysis or peritoneal dialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12.1Mechanism of Action Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents [see MICROBIOLOGY (12.4)].

12.3Pharmacokinetics Absorption The absolute bioavailability of ciprofloxacin when given as an oral tablet is approximately 70% with no substantial loss by first pass metabolism. Ciprofloxacin maximum serum concentrations (Cmax) and area under the curve (AUC) are shown in the chart for the 250 mg to 1000 mg dose range (Table 12). Table 12: Ciprofloxacin Cmax and AUC Following Administration of Single Doses of Ciprofloxacin Tablets to Healthy Subjects Dose (mg) Cmax (mcg/mL) AUC (mcg•hr/mL) 250 1.2 4.8 500 2.4 11.6 750 4.3 20.2 1000 5.4

30.8Maximum serum concentrations are attained 1 to 2 hours after oral dosing. Mean concentrations 12 hours after dosing with 250, 500, or 750 mg are 0.1, 0.2, and 0.4 mcg/mL, respectively. The serum elimination half-life in subjects with normal renal function is approximately 4 hours.

Serum concentrations increase proportionately with doses up to 1000 mg. A 500 mg oral dose given every 12 hours has been shown to produce an AUC equivalent to that produced by an intravenous infusion of 400 mg ciprofloxacin given over 60 minutes every 12 hours. A 750 mg oral dose given every 12 hours has been shown to produce an AUC at steady-state equivalent to that produced by an intravenous infusion of 400 mg given over 60 minutes every 8 hours.

A 750 mg oral dose results in a Cmax similar to that observed with a 400 mg intravenous dose (Table 13). A 250 mg oral dose given every 12 hours produces an AUC equivalent to that produced by an infusion of 200 mg ciprofloxacin given every 12 hours. Table 13: Steady-state Pharmacokinetic Parameters Following Multiple Oral and Intravenous Doses (Adults) Parameters 500 mg 400 mg 750 mg 400 mg every 12 hours, orally every 12 hours, intravenous every 12 hours, orally every 12 hours, intravenous AUC0-24h,ss (μg•h/mL) 27.4* 25.4* 31.6* 32.9** Cmax,ss (μg/mL) 2.97 4.56 3.59 4.07 *:AUC0–12h x 2 **:AUC0-8h x 3 Food When ciprofloxacin tablets are given concomitantly with food, there is a delay in the absorption of the drug, resulting in peak concentrations that occur closer to 2 hours after dosing rather than 1 hour.

The overall absorption of ciprofloxacin tablets, however, is not substantially affected. Avoid concomitant administration of ciprofloxacin tablets with dairy products (like milk or yogurt) or calcium-fortified juices alone since decreased absorption is possible; however, ciprofloxacin tablets may be taken with a meal that contains these products. Distribution The binding of ciprofloxacin to serum proteins is 20% to 40% which is not likely to be high enough to cause significant protein binding interactions with other drugs.

After oral administration, ciprofloxacin is widely distributed throughout the body. Tissue concentrations often exceed serum concentrations in both men and women, particularly in genital tissue including the prostate. Ciprofloxacin is present in active form in the saliva, nasal and bronchial secretions, mucosa of the sinuses, sputum, skin blister fluid, lymph, peritoneal fluid, bile, and prostatic secretions.

Ciprofloxacin has also been detected in lung, skin, fat, muscle, cartilage, and bone. The drug diffuses into the cerebrospinal fluid (CSF); however, CSF concentrations are generally less than 10% of peak serum concentrations. Low levels of the drug have been detected in the aqueous and vitreous humors of the eye.

Metabolism Four metabolites have been identified in human urine which together account for approximately 15% of an oral dose. The metabolites have antimicrobial activity, but are less active than unchanged ciprofloxacin. Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism.

Co-administration of ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of…

📦 How Supplied / Storage and Handling 175 words ▾

Ciprofloxacin Tablets, USP are available as white, round, film-coated tablets containing 250 mg ciprofloxacin. The 250 mg tablet is imprinted with “WW927” on one side. Ciprofloxacin Tablets, USP are available as white medium capsule shape film-coated tablet containing 500 mg ciprofloxacin.

The 500 mg tablet is engraved with “WW928” from one side and plain from the other side. Ciprofloxacin Tablets, USP are available as white, large capsule shaped, film-coated tablets containing 750 mg ciprofloxacin. The 750 mg tablet is imprinted with “ WW929’’ on one side.

Ciprofloxacin Tablets, USP 750 mg are available in bottles of 50’s and 100’s and unit dose boxes of 100 tablets. Strength Tablet Identification NDC CODE Bottles of 30’s 250 mg 500 mg WW927 WW928 Bottles of 50’s 750 mg WW929 Bottles of 100’s 250 mg 500 mg 750 mg WW927 WW928 WW929 Bottles of 500’s 250 mg 500 mg WW927 WW928 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

📋 Description 163 words ▾

Ciprofloxacin tablets, USP (ciprofloxacin hydrochloride) are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8.

Its empirical formula is C17H18FN3O3•HCl•H2O and its chemical structure is as follows: [ciprofloxacin hydrochloride chemical structure] Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows: [ciprofloxacin chemical structure] Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths.

Ciprofloxacin tablets, USP are white to slightly yellowish. The inactive ingredients are colloidal silicon dioxide, corn starch, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, purified water, sodium starch glycolate. The film-coating suspension (Opadry white 321A180025) contains the following inactive ingredients: glycerol monocaprylocaprate, macrogol (PEG) polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc and titanium dioxide.

💬 Medication Guide ~3 min read ▾

Medication Guide Ciprofloxacin Tablets USP (sip-roh-flok-suh-sin) Read this Medication Guide before you start taking ciprofloxacin tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about ciprofloxacin tablets? Ciprofloxacin tablets, a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death.

If you get any of the following serious side effects while you take ciprofloxacin tablets, you should stop taking ciprofloxacin tablets immediately and get medical help right away. 1. Tendon rupture or swelling of the tendon (tendinitis). • Tendon problems can happen in people of all ages who take ciprofloxacin tablets.

Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include: ○ Pain ○ swelling ○ tears and swelling of the tendons including the back of the ankle (Achilles), shoulder, hand, thumb, or other tendon sites. • The risk of getting tendon problems while you take ciprofloxacin tablets is higher if you: ○ are over 60 years of age ○ are taking steroids (corticosteroids) ○ have had a kidney, heart or lung transplant • Tendon problems can happen in people who do not have the above risk factors when they take ciprofloxacin tablets. • Other reasons that can increase your risk of tendon problems can include: ○ physical activity or exercise ○ kidney failure ○ tendon problems in the past, such as in people with rheumatoid arthritis (RA) • Stop taking ciprofloxacin tablets immediately and get medical help right away at the first sign of tendon pain, swelling or inflammation.

The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons. • Tendon rupture can happen while you are taking or after you have finished taking ciprofloxacin tablets. Tendon ruptures can happen within hours or days of taking ciprofloxacin tablets and have happened up to several months after people have finished taking their fluoroquinolone. • Stop taking ciprofloxacin tablets immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture: ○ hear or feel a snap or pop in a tendon area ○ bruising right after an injury in a tendon area ○ unable to move the affected area or bear weight The tendon problems may be permanent.

2. Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including ciprofloxacin tablets.

Stop taking ciprofloxacin tablets immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet: • pain • numbness • burning • weakness • tingling Ciprofloxacin tablets may need to be stopped to prevent permanent nerve damage. 3. Central Nervous System (CNS) effects.

Mental health problems and seizures have been reported in people who take fluoroquinolone antibacterial medicines, including ciprofloxacin tablets. Tell your healthcare provider if you have a history of seizures before you start taking ciprofloxacin tablets. CNS side effects may happen as soon as after taking the first dose of ciprofloxacin tablets.

Stop taking ciprofloxacin tablets immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior: seizures hear voices, see things, or sense things that are not there (hallucinations) feel restless or agitated tremors feel anxious or nervous confusion depression reduced awareness of surroundings trouble sleeping nightmares feel lightheaded or dizzy feel more suspicious (paranoia) suicidal thoughts or acts headac…

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

sedative: A substance with a calming effect that can also cause drowsiness.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

angina pectoris: Chest pain or a squeezing feeling that happens when the heart muscle does not get enough blood and oxygen.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

arthralgia: Joint pain.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Clostridioides difficile: A type of gut germ that can overgrow and cause severe, watery diarrhea, often after antibiotic use.

Cmax: The highest level a medicine reaches in the blood after a dose is taken.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

depression: A lasting low mood with loss of interest that affects everyday life.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diarrhea: Loose, watery bowel movements that happen more often than normal.

diplopia: Double vision, or seeing two images of a single object.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

endpoint: A specific outcome, such as a symptom or lab value, that a study measures to judge whether a treatment works.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

exfoliative dermatitis: Widespread redness with heavy scaling or peeling of the skin over most of the body.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

gastrointestinal bleeding: Bleeding anywhere along the digestive tract, from the food pipe down to the bowel.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemoptysis: Coughing up blood or bloody mucus from the lungs or airways.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

in utero: Inside the womb, describing a baby before it is born.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

INR: A blood test result that shows how quickly blood clots, often used to monitor blood-thinning medicines.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

interstitial nephritis: Inflammation of the tissue between the kidney's tiny filtering tubes, sometimes triggered by a medicine, that can reduce kidney function.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myalgia: Muscle pain or aching.

myasthenia gravis: A long-term condition where muscles tire and grow weak easily, often affecting the eyes, face, and swallowing.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

perforation: A hole that forms all the way through the wall of the stomach or intestine.

peripheral neuropathy: Damage to the nerves outside the brain and spinal cord, often causing numbness, tingling, or pain in the hands and feet.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

photosensitivity: An unusually strong skin reaction, such as burning or rash, after being in sunlight or other ultraviolet light.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

prothrombin time: A blood test that measures how many seconds it takes for blood to form a clot.

pruritus: Itching of the skin.

psychosis: A state of losing touch with reality, such as seeing or hearing things that are not there or holding false beliefs.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

renal excretion: Removal of a medicine from the body through the kidneys into the urine.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

serum creatinine: A waste product measured in a blood test; higher levels can mean the kidneys are not filtering as well as normal.

status epilepticus: A seizure that lasts a long time, or repeated seizures without recovery in between, which is a medical emergency.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

tendinitis: Swelling and irritation of a tendon, the cord that attaches muscle to bone.

tendon rupture: A tear or complete break of a tendon, the tough cord that connects muscle to bone.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 72189-0299-20 · DirectRx 72189-0301-14 · DirectRx →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

CIPROFLOXACIN 500 mg Tablet, Film Coated, 20-count

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