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CIPROFLOXACIN 500 mg Tablet, 20-count

by DIRECT RX · 20 TABLET in 1 BOTTLE (61919-361-20)

NDC 61919-0361-20

🏷️ FDA NDC (as labeled) 61919-361-20 billing pads the product segment with a zero

This package

Contains20-count Pack sizes5 compare ↓

Also comes in: 6 tablets 61919-0361-06 10 tablets 61919-0361-10 14 tablets 61919-0361-14 30 tablets 61919-0361-30

Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA

🗂️ Data synced Jul 14, 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 ↗

⚠️

Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 61919-361-20

Product NDC 61919-361

11-digit billing NDC 61919036120

NCPDP billing unit EA — each (per item)

Application # ANDA076639

SPL Set ID 4171a441-8719-5977-e054-00144ff88e88

Chemical class Quinolone Antimicrobial [EPC], Quinolones

DEA schedule Non-controlled

Marketing category ANDA

Marketing status Discontinued

FDA listing status Inactivated by FDA (certified through Dec 2024)

Route ORAL

Dosage form TABLET

Substance CIPROFLOXACIN HYDROCHLORIDE

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

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 61919-361-20 — 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 → 61919-0361-20. 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.

🏭 Manufacturer & labeler

LabelerDIRECT RX

Application holderUNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD

FDA applicationANDA076639 (ANDA)

Labeler code61919

Product typeHuman Prescription Drug

Portfolio204 products on file

🔎 All NDCs from DIRECT RX

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.

💊 What it looks like

Color white

ShapeCapsule

ImprintP;500

Size18 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 68401960MK
Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
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 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 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.

9 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 · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 6 tablets 10 tablets 14 tablets 30 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 mg 72189-0300-06	DirectRx	6 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	—
Ciprofloxacin 500 mgthis 61919-0361-20	DIRECT	20 tablets	—	AB	Discontinued	—

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

📍

2026

Currently FDA-listed

listed with the FDA

🔓

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
61919-0361-06	6 TABLET in 1 BOTTLE (61919-361-06)	2016-11-16	Inactivated by FDA
61919-0361-10	10 TABLET in 1 BOTTLE (61919-361-10)	2016-11-16	Inactivated by FDA
61919-0361-14	14 TABLET in 1 BOTTLE (61919-361-14)	2016-11-16	Inactivated by FDA
61919-0361-20 You're viewing this	20 TABLET in 1 BOTTLE (61919-361-20)	2016-11-16	Inactivated by FDA
61919-0361-30	30 TABLET in 1 BOTTLE (61919-361-30)	2016-11-16	Inactivated by FDA

You're viewing one of 5 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 61919-0361-20?

NDC 61919-0361-20 is a 20-count package — 20 tablet in 1 bottle.

What is the difference between NDC 61919-0361-20 and NDC 61919-0361-06?

Both are CIPROFLOXACIN 500 mg Tablet — the drug itself is identical. NDC 61919-0361-20 is the 20-count package, while NDC 61919-0361-06 is the 6 tablets package.

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

Bill NDC 61919-0361-20 — the 11-digit billing format is 61919036120. 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 No longer marketed (per FDA listing data)

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	✓ Available
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	✓ Available
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.

What does the discontinued status mean for this NDC?

The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.

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 61919-361-20, 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: 61919-0361-20, written without dashes as 61919036120. 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 61919-0361-20, the first segment (61919) is the labeler code FDA assigned to DIRECT RX; the middle segment (0361) 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.

Does this product come in other package sizes?

Yes — the FDA directory lists 4 other package presentations of this same product, including 6 tablets (61919-0361-06), 10 tablets (61919-0361-10), 14 tablets (61919-0361-14). 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?

DIRECT RX 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?

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📄 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.

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

🚨 Boxed Warning 77 words ▾

Fluoroquinolones, including ciprofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart, or lung transplants [see WARNINGS AND PRECAUTIONS (5.1)]. Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis.

Avoid ciprofloxacin in patients with known history of myasthenia gravis [see WARNINGS AND PRECAUTIONS (5.2)].

🎯 Indications and Usage ~2 min read ▾

Ciprofloxacin is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below.

1.1Urinary Tract Infections Ciprofloxacin is indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.

1.2Acute Uncomplicated Cystitis Ciprofloxacin is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus.

1.3Chronic Bacterial Prostatitis Ciprofloxacin is indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.

1.4Lower Respiratory Tract Infections Ciprofloxacin is 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. Also, ciprofloxacin is indicated for the treatment of acute exacerbations of chronic bronchitis caused by Moraxella catarrhalis [see INDICATIONS AND USAGE (1.15)].

1.5Acute Sinusitis Ciprofloxacin is indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.

1.6Skin and Skin Structure Infections Ciprofloxacin is 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.

1.7Bone and Joint Infections Ciprofloxacin is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

1.8Complicated Intra-Abdominal Infections Ciprofloxacin is 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.

1.9Infectious Diarrhea Ciprofloxacin is 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.

1.10Typhoid Fever (Enteric Fever) Ciprofloxacin is 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.

1.11Uncomplicated Cervical and Urethral Gonorrhea Ciprofloxacin is indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae [see WARNINGS AND PRECAUTIONS (5.16)].

1.12Complicated Urinary Tract Infections and Pyelonephritis Ciprofloxacin is indicated in pediatric patients one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to Escherichia coli [see INDICATIONS AND USAGE (1.15) and USE IN SPECIFIC POPULATIONS (8.4)].

1.13 Inhalational Anthrax (post-exposure) Ciprofloxacin is indicated in adults and p…

⏱️ Dosage and Administration ~3 min read ▾

Ciprofloxacin 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. Table 1: Adult Dosage Guidelines * 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). † Used in conjunction with metronidazole. ‡ Begin drug administration as soon as possible after suspected or confirmed exposure.

Infection Dose Frequency Usual Durations* Urinary Tract 250 mg- 500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500 mg -750 mg every 12 hours 7 to 14 days Acute Sinusitis 500 mg every 12 hours 10 days Skin and Skin Structure 500 mg -750 mg every 12 hours 7 to 14 days Bone and Joint 500 mg -750 mg every 12 hours 4 to 8 weeks Complicated Intra–Abdominal† 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)‡ 500 mg every 12 hours 60 days Plague‡ 500 mg - 750 mg every 12 hours 14 days Conversion of IV to Oral Dosing in Adults Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets or Oral Suspension when clinically indicated at the discretion of the physician (Table 2) [see CLINICAL PHARMACOLOGY (12.3)].

Table 2: Equivalent AUC Dosing Regimens Ciprofloxacin 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 should be administered as described in Table 3. Table 3: Pediatric Dosage Guidelines * 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). † Begin drug administration as soon as possible after suspected or confirmed exposure. ‡ Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis. 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 to 21 days * Inhalational Anthrax (Post-Exposure) † 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 days Plague † , ‡ 15 mg/kg (maximum 500 mg per dose) Every 12 to 8 hours 10 -21 days

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 Function Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 - 50 250 mg - 500 mg every 12 hours 5 - 29 250 mg - 500 mg…

💊 Dosage Forms and Strengths 67 words ▾

3.1Tablets 250 mg white to slightly yellowish, film-coated, round, biconvex, embossed with word “P” on one side and 250 on reverse side 500 mg white to slightly yellowish, film-coated, capsule shaped, embossed with the word “P” on one side and “500” on reverse side 750 mg white to slightly yellowish, film-coated, capsule shaped, embossed with the word “P” on one side and “750” on reverse side

⛔ Contraindications 45 words ▾

4.1Hypersensitivity Ciprofloxacin is 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 (5.3)].

4.2Tizanidine Concomitant administration with tizanidine is contraindicated [see DRUG INTERACTIONS (7)].

⚠️ Warnings and Cautions ~2 min read ▾

5.1Tendinopathy and Tendon Rupture Fluoroquinolones, including ciprofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, 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.

Inflammation and tendon rupture can occur, sometimes bilaterally, even within the first 48 hours, during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Ciprofloxacin should be used with caution in patients with a history of tendon disorders, ciprofloxacin should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon[see ADVERSE REACTIONS (6.2)

5.2Exacerbation of Myasthenia Gravis Fluoroquinolones, including ciprofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis. [see ADVERSE REACTIONS (6.2).]

5.3Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy, including ciprofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions.

Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, including intubation, as indicated. [see ADVERSE REACTIONS (6.1).]

5.4Other Serious and Sometimes Fatal Reactions Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported in patients receiving therapy with quinolones, including ciprofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following: Fever, rash, or severe dermatologic reactions (for example, toxic epidermal necrolysis, Stevens-Johnson syndrome); Vasculitis; arthralgia; myalgia; serum sickness; Allergic pneumonitis; Interstitial nephritis; acute renal insufficiency or failure; Hepatitis; jaundice; acute hepatic necrosis or failure; Anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.

Discontinue ciprofloxacin immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted [see ADVERSE REACTIONS (6.1, 6.2)].

5.5Hepatotoxicity Cases of severe hepatotoxicity, including hepatic necrosis, life-threatening hepatic failure, and fatal events, have been reported with ciprofloxacin. Acute liver injury is…

🤒 Adverse Reactions ~2 min read ▾

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

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 6: 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 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 or pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years) in an international multicenter trial. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with…

👥 Use in Specific Populations ~3 min read ▾

8.1Pregnancy Teratogenic Effects. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother.

An expert review of published data on experiences with ciprofloxacin use during pregnancy by TERIS–the Teratogen Information System–concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (quantity and quality of data = fair), but the data are insufficient to state that there is no risk.2 A controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to ciprofloxacin and 68% first trimester exposures) during gestation.3In 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).4 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.2,3 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. Reproduction studies have been performed in rats and mice using oral doses up to 100 mg/kg (0.6 and 0.3 times the maximum daily human dose based upon body surface area, respectively) and have revealed no evidence of harm to the fetus due to ciprofloxacin.

In rabbits, oral ciprofloxacin dose levels of 30 and 100 mg/kg (approximately 0.4-and 1.3-times the highest recommended therapeutic dose based upon body surface area) produced gastrointestinal toxicity resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose level. After intravenous administration of doses up to 20 mg/kg (approximately 0.3-times the highest recommended therapeutic dose based upon body surface area), no maternal toxicity was produced and no embryotoxicity or teratogenicity was observed.

8.3Nursing Mothers Ciprofloxacin is excreted in human milk. The amount of ciprofloxacin absorbed by the nursing infant is unknown. Because of the potential risk of serious adverse reactions (including articular damage) in infants nursing from mothers taking ciprofloxacin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls. Quinolones, including ciprofloxacin, cause arthropathy in juvenile animals [see WARNINGS AND PRECAUTIONS (5.11) and NONCLINICAL TOXICOLOGY (13.2)]. Complicated Urinary Tract Infection and Pyelonephritis Ciprofloxacin is indicated for the treatment of cUTI and py…

🆘 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 and area under the curve are shown in the chart for the 250 mg to 1000 mg dose range (Table 10). Table 10: Maximum Serum Concentrations and Areas Under the Curve Dose (mg) Maximum Serum Concentration (mcg/mL) Area Under Curve (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 area under the serum concentration time curve (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. 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 11). Table 11: Steady-state Pharmacokinetic Parameters Following Multiple Oral and IV Doses * AUC 0 to 12h † AUC 24h = AUC 0 to 12h x 2 ‡ AUC 24h = AUC 0 to 8h x 3 Parameters 500 mg 400 mg 750 mg 400 mg Every 12 hours, orally Every 12 hours, intravenous Every 12 hours, orally Every 8 hours, IV AUC (mcg•hr/mL) 13.7* 12.7* 31.6† 32.9‡ Cmax (mcg/mL) 2.97 4.56 3.59

4.07Food When ciprofloxacin tablet is 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 with dairy products (like milk or yogurt) or calcium-fortified juices alone since decreased absorption is possible; however, ciprofloxacin may be taken with a meal that contains these products With oral administration, a 500 mg dose, given as 10 mL of the 5% ciprofloxacin suspension (containing 250 mg ciprofloxacin/5mL) is bioequivalent to the 500 mg tablet.

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 ciprof…

📦 How Supplied / Storage and Handling 121 words ▾

Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP are available as round, biconvex white to slightly yellowish film coated tablets containing 250 mg of ciprofloxacin. The 250 mg tablet is embossed with the word “P” on one side and “250” on reverse side. Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP is also available as capsule shaped, white to slightly yellowish film coated tablets containing 500mg of ciprofloxacin.

The 500 mg tablet is embossed with the word “P” on one side and “500” on reverse side. Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP is also available as capsule shaped, white to slightly yellowish film coated tablets containing 750 mg of ciprofloxacin. The 750 mg tablet is embossed with the word “P” on one side and “750” on reverse side.

📋 Description 106 words ▾

Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP 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 Structural Formula 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 pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water.

💬 Patient Medication Information ~3 min read ▾

Advise the patient to read the FDA-approved patient labeling (MEDICATION GUIDE) Antibacterial Resistance Inform patients that antibacterial drugs including ciprofloxacin should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When ciprofloxacin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ciprofloxacin, or other antibacterial drugs in the future. Administration with Food, Fluids, and Concomitant Medications Inform patients that ciprofloxacin may be taken with or without food. Inform patients to drink fluids liberally while taking ciprofloxacin to avoid formation of highly concentrated urine and crystal formation in the urine.

Inform patients that antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine should be taken at least two hours before or six hours after ciprofloxacin administration. Ciprofloxacin should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone since absorption of ciprofloxacin may be significantly reduced; however, ciprofloxacin may be taken with a meal that contains these products. Serious and Potentially Serious Adverse Reactions Inform patients of the following serious adverse reactions that have been associated with ciprofloxacin or other fluoroquinolone use: Tendon Disorders: Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue ciprofloxacin treatment.

The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Exacerbation of Myasthenia Gravis: Instruct patients to inform their physician of any history of myasthenia gravis. Instruct patients to notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties.

Hypersensitivity Reactions: Inform patients that ciprofloxacin can cause hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction. Hepatotoxicity: Inform patients that severe hepatotoxicity (including acute hepatitis and fatal events) has been reported in patients taking ciprofloxacin.

Instruct patients to inform their physician if they experience any signs or symptoms of liver injury including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements or dark colored urine. Convulsions: Inform patients that convulsions have been reported in patients receiving fluoroquinolones, including ciprofloxacin. Instruct patients to notify their physician before taking this drug if they have a history of convulsions.

Neurologic Adverse Effects (for example, dizziness, lightheadedness, increased intracranial pressure): Inform patients that they should know how they react to ciprofloxacin before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Instruct patients to notify their physician if persistent headache with o…

💬 Medication Guide ~3 min read ▾

Medication Guide for Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg Read this Medication Guide before you start taking ciprofloxacin 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? Ciprofloxacin a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects could result in death.

If you get any of the following serious side effects while you take ciprofloxacin, get medical help right away. Talk with your healthcare provider about whether you should continue to take ciprofloxacin. Tendon rupture or swelling of the tendon (tendinitis).

Tendon problems can happen in people of all ages who take ciprofloxacin. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include: pain swelling tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites.

The risk of getting tendon problems while you take ciprofloxacin 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. 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) Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation.

Stop taking ciprofloxacin until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. 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. Talk to your healthcare provider about the risk of tendon rupture with continued use of ciprofloxacin. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.

Tendon rupture can happen while you are taking or after you have finished taking ciprofloxacin. Tendon ruptures have happened up to several months after people have finished taking their fluoroquinolone. 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 Worsening of myasthenia gravis (a problem that causes muscle weakness).

Fluoroquinolones like ciprofloxacin may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems. See “What are the possible side effects of ciprofloxacin?” What is ciprofloxacin?

Ciprofloxacin is a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat certain infections caused by certain germs called bacteria. These bacterial infection include: urinary tract infection chronic prostate infection lower respiratory tract infection sinus infection skin infection bone and joint infection nosocomial pneumonia intra-abdominal infection, complicated infectious diarrhea typhoid (enteric) fever cervical and urethral gonorrhea, uncomplicated people with a low white blood cell count and a fever inhalational anthrax plague Studies of ciprofloxacin for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people.

Ciprofloxacin is also used in children younger than 18 years of age to treat complicated urinary tract and kidney infectionsand who may have breathed in anthrax germs, have plague or have been exposed to plague germs. Children younger th…

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

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

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

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.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

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).

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.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

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

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

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

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.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

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.

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.

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.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

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.

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.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

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.

Nonclinical Toxicology: The label section summarizing safety findings from laboratory and animal studies, rather than from studies in people.

nursing infant: A baby who is being fed breast milk.

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.

pancytopenia: A low level of all three main blood cell types at once: red cells, white cells, and platelets.

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.

pneumonitis: Inflammation of the lung tissue that is not caused by an infection and can lead to cough and breathlessness.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

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

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.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

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.

serum sickness: A delayed reaction, usually one to two weeks after exposure, causing fever, rash, and joint pain as the body reacts to a foreign substance.

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.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

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 ↗

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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, 20-count

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