Home › NDC Lookup › Ingredients › Metronidazole › 63187-0035-04
Metronidazole 500 mg Tablet, 4-count — NDC 63187-0035-04 package photo

Metronidazole 500 mg Tablet, 4-count

by Proficient Rx LP · 4 TABLET in 1 BOTTLE (63187-035-04)
NDC 63187-0035-04
🏷️ FDA NDC (as labeled) 63187-035-04 billing pads the product segment with a zero
This package
Contains4-count Pack sizes7 compare ↓
Also priced by: Part D plans $0.2060/unit — full pricing hub ↓
Also comes in: 14 tablets 63187-0035-14 21 tablets 63187-0035-21 28 tablets 63187-0035-28 30 tablets 63187-0035-30 60 tablets 63187-0035-60 90 tablets 63187-0035-90
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

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

🆔 Identity & classification

FDA NDC (as labeled) 63187-035-04
Product NDC 63187-035
11-digit billing NDC 63187003504
NCPDP billing unit EA — each (per item)
RxCUI 311681
UNII 140QMO216E
UPC 0363187035044
Application # ANDA070033
SPL Set ID e313c7d9-fb7b-4d0f-bccf-cc72ac5ef205
Established class (EPC) Nitroimidazole Antimicrobial
Chemical class Nitroimidazoles
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1990-09-30
Route ORAL
Dosage form TABLET
Substance METRONIDAZOLE
GPI-14 16000035000310
GPI class metroNIDAZOLE
GCN Seq No 009592
GCN 43032
HICL code 004157
Ingredient (HICL) Metronidazole
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W4
Therapeutic class — intermediate (HIC2) Antiparasitics
HIC3 code W4E
Therapeutic class — specific (HIC3) Anaerobic Antiprotozoal-Antibacterial Agents
AHFS code 08:30.04.00
AHFS class Amebicides
FDB label name METRONIDAZOLE 500 MG TABLET
FDB brand name Metronidazole
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 63187-035-04 — 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 → 63187-0035-04. 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 Nitroimidazole Antimicrobial class.

Pharmacologic class Nitroimidazole Antimicrobial
Drug family (ATC) Nitroimidazole derivatives, Antiinfectives and antiseptics for local oral treatment, Other chemotherapeutics
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

LabelerProficient Rx LP
Application holderPLIVA INC
FDA applicationANDA070033 (ANDA)
Labeler code63187
First marketedSep 1990
Product typeHuman Prescription Drug
Portfolio1,723 products on file
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 METRONIDAZOLE 500 MG TABLET Ingredient Metronidazole
📖 What it is MedlinePlus · NLM

Metronidazole is used to treat certain infections in the body caused by bacteria including sexually transmitted diseases (STDs) and bacterial vaginosis (an infection caused by too much of certain types of harmful bacteria in the vagina) in women. Metronidazole is in a class of medications called nitroimidazole antimicrobials. It works by stopping the growth of bacteria. Antibiotics will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • This is one of the most important things to know about metronidazole. If you drink alcohol — or consume products containing propylene glycol — while taking it, you can have a prett...
  • Why do I have to avoid alcohol while taking this?
  • Yes, completely normal and actually really important. Trichomoniasis is a sexually transmitted infection, so even if your partner has no symptoms, they can still carry the parasite...
  • My partner and I both have to take this for trichomoniasis — is that normal?
📖 Read our full Metronidazole guide →
7
Nutrient depletion considerations

Metronidazole may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Metronidazole 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
ShapeOval
ImprintPLIVA;334
Size16 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 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 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 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.

3 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 systemPer eachPer 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 $0.2060 $0.82 / 4 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metronidazole 500 mg 00904-7126-61 Major 100 tablets $0.101 AB Availability likely —
Metronidazole 500 mg 16571-0664-01 Rising 100 tablets $0.101 AB Availability likely —
Metronidazole 500 mg 23155-0652-01 Heritage 100 tablets $0.101 AB Availability likely —
Metronidazole 500 mg 29300-0227-01 Unichem 100 tablets $0.101 AB Availability likely —
Metronidazole 500 mg 50111-0334-01 Teva 100 tablets $0.101 AB Availability likely —
Metronidazole 500 mg 50268-0535-15 AvPAK 50 tablets $0.101 AB Availability likely —
metronidazole 500 mg 58657-0934-01 Method 100 tablets $0.101 — Availability likely —
Metronidazole 500 mg 60687-0550-01 American 100 tablets $0.101 — Availability likely —
Metronidazole 500 mg 62135-0796-90 Chartwell 90 tablets $0.101 AB Availability likely —
Metronidazole 500 mg 68001-0365-00 BluePoint 100 tablets $0.101 AB Availability likely —
metronidazole 500 mg 72578-0008-01 Viona 100 tablets $0.101 AB Availability likely —
Metronidazole 500 mg 65862-0695-01 Aurobindo 100 tablets $0.123 AB FDA listed —
Metronidazole 500 mg 15955-0389-01 Alembic 100 tablets — AB FDA listed —
Metronidazole 500 mg 46708-0429-30 Alembic 30 tablets — AB FDA listed —
Metronidazole 500 mg 50090-0211-00 A-S 4 tablets — AB FDA listed —
Metronidazole 500 mg 50090-0212-01 A-S 30 tablets — AB FDA listed —
Metronidazole 500 mg 50090-0213-00 A-S 14 tablets — AB FDA listed —
metronidazole 500 mg 51407-0372-01 Golden 100 tablets — — FDA listed —
Metronidazole 500 mg 51655-0441-20 Northwind 20 tablets — AB FDA listed —
Metronidazole 500 mg 54348-0740-00 PharmPak, 1 tablet — AB FDA listed —
Metronidazole 500 mg 55154-8190-00 Cardinal 10 tablets — — FDA listed —
Metronidazole 500 mg 55700-0298-04 Quality 4 tablets — AB FDA listed —
Metronidazole 500 mg 60760-0336-14 St. 14 tablets — AB FDA listed —
metronidazole 500 mg 60760-0539-14 ST. 14 tablets — AB FDA listed —
Metronidazole 500 mg 61919-0032-10 Direct_Rx 10 tablets — AB FDA listed —
Metronidazole 500 mg 62332-0017-30 Alembic 30 tablets — AB FDA listed —
Metronidazole 500 mgthis 63187-0035-04 Proficient 4 tablets — AB FDA listed —
Metronidazole 500 mg 63187-0827-04 Proficient 4 tablets — AB FDA listed —
Metronidazole 500 mg 63629-1386-00 Bryant 40 tablets — AB FDA listed —
Metronidazole 500 mg 63629-7916-01 Bryant 14 tablets — AB FDA listed —
Metronidazole 500 mg 67046-1060-03 Coupler 30 tablets — AB FDA listed —
Metronidazole 500 mg 67046-1173-03 Coupler 30 tablets — AB FDA listed —
Metronidazole 500 mg 67296-0078-01 Redpharm 30 tablets — AB FDA listed —
Metronidazole 500 mg 67296-2152-01 Redpharm 14 tablets — AB FDA listed —
Metronidazole 500 mg 68071-1876-00 NuCare 42 tablets — AB FDA listed —
Metronidazole 500 mg 68071-2280-04 NuCare 4 tablets — AB FDA listed —
Metronidazole 500 mg 68071-2288-04 NuCare 4 tablets — AB FDA listed —
Metronidazole 500 mg 68071-2399-04 NuCare 4 tablets — AB FDA listed —
metronidazole 500 mg 68071-2409-01 NuCare 4 tablets — AB FDA listed —
Metronidazole 500 mg 68071-5073-02 NuCare 21 tablets — AB FDA listed —
metronidazole 500 mg 68788-7815-01 Preferred 14 tablets — AB FDA listed —
Metronidazole 500 mg 68788-8674-01 Preferred 14 tablets — AB FDA listed —
metronidazole 500 mg 69292-0208-01 AMICI 100 tablets — — FDA listed —
Metronidazole 500 mg 70518-0058-00 REMEDYREPACK 14 tablets — AB FDA listed —
Metronidazole 500 mg 70518-0088-02 REMEDYREPACK 14 tablets — AB FDA listed —
Metronidazole 500 mg 70518-1240-00 REMEDYREPACK 4 tablets — AB FDA listed —
Metronidazole 500 mg 70518-1241-00 REMEDYREPACK 14 tablets — AB FDA listed —
Metronidazole 500 mg 70518-2305-01 REMEDYREPACK 4 tablets — AB Discontinued —
metronidazole 500 mg 70518-2663-00 REMEDYREPACK 4 tablets — AB FDA listed —
Metronidazole 500 mg 70518-3110-00 REMEDYREPACK 30 tablets — AB Discontinued —
Metronidazole 500 mg 70518-3265-01 REMEDYREPACK 4 tablets — AB FDA listed —
Metronidazole 500 mg 70771-1046-01 Zydus 100 tablets — AB FDA listed —
Metronidazole 500 mg 71209-0063-02 Cadila 50 tablets — AB FDA listed —
Metronidazole 500 mg 71335-0358-00 Bryant 40 tablets — AB FDA listed —
Metronidazole 500 mg 71335-1681-00 Bryant 40 tablets — AB FDA listed —
metronidazole 500 mg 71335-1703-00 Bryant 40 tablets — AB FDA listed —
Metronidazole 500 mg 71335-1922-00 Bryant 40 tablets — AB FDA listed —
Metronidazole 500 mg 71335-2640-01 Bryant 14 tablets — AB FDA listed —
metronidazole 500 mg 71335-2681-01 Bryant 14 tablets — AB FDA listed —
Metronidazole 500 mg 72162-2403-02 Bryant 14 tablets — AB FDA listed —
Metronidazole 500 mg 72789-0005-14 PD-Rx 14 tablets — AB FDA listed —
Metronidazole 500 mg 72789-0007-04 PD-Rx 4 tablets — AB FDA listed —
Metronidazole 500 mg 72789-0011-04 PD-Rx 4 tablets — AB FDA listed —
metronidazole 500 mg 76420-0801-01 Asclemed 100 tablets — AB FDA listed —
metronidazole 500 mg 82868-0014-14 Northwind 14 tablets — AB FDA listed —
Metronidazole 500 mg 82982-0072-14 Pharmasource 14 tablets — AB Discontinued —
metronidazole 500 mg 85766-0024-01 Sportpharm 100 tablets — AB FDA listed —
Metronidazole 500 mg 85742-0025-24 Kanchan 50 tablets — AB FDA listed —
Metronidazole 500 mg 72162-2678-01 Bryant 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

🏛️
1990
On the market since
Sep 1990
📍
2026
Currently FDA-listed
36 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 Metronidazole — the program that covers self-administered drugs. 23 manufacturers.
⚠️ 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 Metronidazole. 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
$12.08M
Claims incl. refills
571.7K
Beneficiaries
500.3K
Spend / beneficiary
$24.15
Spend / claim
$21.13
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Metronidazole — the ingredient across all brands.

Top reported reactions

Nausea4,812
Diarrhoea4,197
Vomiting3,393
Pyrexia3,294
Drug Hypersensitivity3,160
Pain3,080
Abdominal Pain3,057

Age at onset

Neonate223
Infant82
Child252
Adolescent271
Adult5,483
Elderly2,552

Reporter sex

64,630 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization27,458
Death6,867
Life-threatening5,251
Disabling2,508
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,750 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63187-0035-04 You're viewing this 4 TABLET in 1 BOTTLE (63187-035-04) 2021-12-14 Active
63187-0035-14 14 TABLET in 1 BOTTLE (63187-035-14) 2018-11-01 Active
63187-0035-21 21 TABLET in 1 BOTTLE (63187-035-21) 2018-11-01 Active
63187-0035-30 30 TABLET in 1 BOTTLE (63187-035-30) 2018-11-01 Active
63187-0035-60 60 TABLET in 1 BOTTLE (63187-035-60) 2021-12-14 Active
63187-0035-90 90 TABLET in 1 BOTTLE (63187-035-90) 2021-12-14 Active
63187-0035-28 28 TABLET in 1 BOTTLE (63187-035-28) 2024-08-23 Active

You're viewing the smallest of 7 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 63187-0035-04?
NDC 63187-0035-04 is a 4-count package — 4 tablet in 1 bottle.
What is the difference between NDC 63187-0035-04 and NDC 63187-0035-14?
Both are Metronidazole 500 mg Tablet — the drug itself is identical. NDC 63187-0035-04 is the 4-count package, while NDC 63187-0035-14 is the 14 tablets package.
What NDC number is used to bill for this package of Metronidazole 500 mg Tablet?
Bill NDC 63187-0035-04 — the 11-digit billing format is 63187003504. 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 ✓ 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.
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 63187-035-04, 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: 63187-0035-04, written without dashes as 63187003504. 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 63187-0035-04, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0035) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Proficient Rx LP. 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 6 other package presentations of this same product, including 14 tablets (63187-0035-14), 21 tablets (63187-0035-21), 28 tablets (63187-0035-28). 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?
Proficient Rx LP 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.
🚨 Boxed Warning 🎯 Indications and Usage ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🚨 Boxed Warning 39 words ▾

WARNING Metronidazole has been shown to be carcinogenic in mice and rats (see PRECAUTIONS ). Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below.

🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE Symptomatic Trichomoniasis Metronidazole Tablets USP are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis Metronidazole Tablets USP are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite.

Treatment of Asymptomatic Sexual Partners T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one.

In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets USP in cases of reinfection.

Amebiasis Metronidazole Tablets USP are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole tablets USP therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections Metronidazole Tablets USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.

Indicated surgical procedures should be performed in conjunction with metronidazole tablets USP therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets USP. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group ( B. fragilis,B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus ), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species.

SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species , Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B.fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species.

BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group.

ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets USP and other antibacterial drugs, metronidazole tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are avail…

⛔ Contraindications 127 words ▾

CONTRAINDICATIONS Hypersensitivity Metronidazole tablets are contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. In patients with trichomoniasis, metronidazole is contraindicated during the first trimester of pregnancy (see PRECAUTIONS ). Psychotic Reaction With Disulfiram Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently.

Do not administer metronidazole to patients who have taken disulfiram within the last two weeks (see PRECAUTIONS , Drug Interactions ). Interaction With Alcohol Use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. Discontinue consumption of alcohol or products containing propylene glycol during and for at least three days after therapy with metronidazole (see PRECAUTIONS , Drug Interactions ).

⚠️ Warnings 157 words ▾

WARNINGS Central and Peripheral Nervous System Effects Encephalopathy and peripheral neuropathy: Cases of encephalopathy and peripheral neuropathy (including optic neuropathy) have been reported with metronidazole. Encephalopathy has been reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria. CNS lesions seen on MRI have been described in reports of encephalopathy.

CNS symptoms are generally reversible within days to weeks upon discontinuation of metronidazole. CNS lesions seen on MRI have also been described as reversible. Peripheral neuropathy, mainly of sensory type has been reported and is characterized by numbness or paresthesia of an extremity.

Convulsive seizures have been reported in patients treated with metronidazole. Aseptic meningitis: Cases of aseptic meningitis have been reported with metronidazole. Symptoms can occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued.

The appearance of abnormal neurologic signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy (see ADVERSE REACTIONS ).

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The following reactions have been reported during treatment with metronidazole: Central Nervous System: The most serious adverse reactions reported in patients treated with metronidazole have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of metronidazole, patients should be specifically warned about these reactions and should be told to stop the drug and report immediately to their physicians if any neurologic symptoms occur.

In addition, patients have reported headache, syncope, dizziness, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness, and insomnia (see WARNINGS ). Gastrointestinal: The most common adverse reactions reported have been referable to the gastrointestinal tract, particularly nausea, sometimes accompanied by headache, anorexia, and occasionally vomiting; diarrhea; epigastric distress; and abdominal cramping and constipation. Mouth: A sharp, unpleasant metallic taste is not unusual.

Furry tongue, glossitis, and stomatitis have occurred; these may be associated with a sudden overgrowth of Candida which may occur during therapy. Dermatologic: Erythematous rash and pruritus. Hematopoietic: Reversible neutropenia (leukopenia); rarely, reversible thrombocytopenia.

Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic tracings. Hypersensitivity: Urticaria, erythematous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, flushing, nasal congestion, dryness of the mouth (or vagina or vulva), and fever. Renal: Dysuria, cystitis, polyuria, incontinence, and a sense of pelvic pressure.

Instances of darkened urine have been reported by approximately one patient in 100,000. Although the pigment which is probably responsible for this phenomenon has not been positively identified, it is almost certainly a metabolite of metronidazole and seems to have no clinical significance. Other: Proliferation of Candida in the vagina, dyspareunia, decrease of libido, proctitis, and fleeting joint pains sometimes resembling “serum sickness.” Rare cases of pancreatitis, which generally abated on withdrawal of the drug, have been reported.

Patients with Crohn’s disease are known to have an increased incidence of gastrointestinal and certain extraintestinal cancers. There have been some reports in the medical literature of breast and colon cancer in Crohn’s disease patients who have been treated with metronidazole at high doses for extended periods of time. A cause and effect relationship has not been established.

Crohn’s disease is not an approved indication for metronidazole tablets.

🆘 Overdosage 89 words ▾

OVERDOSAGE Single oral doses of metronidazole, up to 15 g, have been reported in suicide attempts and accidental overdoses. Symptoms reported include nausea, vomiting, and ataxia. Oral metronidazole has been studied as a radiation sensitizer in the treatment of malignant tumors.

Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 to 10.4 g every other day. Treatment of Overdosage There is no specific antidote for metronidazole overdose; therefore, management of the patient should consist of symptomatic and supportive therapy.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Absorption Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms. Following oral administration, metronidazole is well absorbed, with peak plasma concentrations occurring between one and two hours after administration. Plasma concentrations of metronidazole are proportional to the administered dose.

Oral administration of 250 mg, 500 mg, or 2,000 mg produced peak plasma concentrations of 6 mcg/mL, 12 mcg/mL, and 40 mcg/mL, respectively. Studies reveal no significant bioavailability differences between males and females; however, because of weight differences, the resulting plasma levels in males are generally lower. Distribution Metronidazole is the major component appearing in the plasma, with lesser quantities of metabolites also being present.

Less than 20% of the circulating metronidazole is bound to plasma proteins. Metronidazole appears in cerebrospinal fluid, saliva, and breast milk in concentrations similar to those found in plasma. Bactericidal concentrations of metronidazole have also been detected in pus from hepatic abscesses.

Metabolism/Excretion The major route of elimination of metronidazole and its metabolites is via the urine (60% to 80% of the dose), with fecal excretion accounting for 6% to 15% of the dose. The metabolites that appear in the urine result primarily from side-chain oxidation [1-(β-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole and 2-methyl-5-nitroimidazole-1-yl-acetic acid] and glucuronide conjugation, with unchanged metronidazole accounting for approximately 20% of the total. Both the parent compound and the hydroxyl metabolite possess in vitro antimicrobial activity.

Renal clearance of metronidazole is approximately 10 mL/min/1.73 m 2 . The average elimination half-life of metronidazole in healthy subjects is eight hours. Renal Impairment Decreased renal function does not alter the single-dose pharmacokinetics of metronidazole.

Subjects with end-stage renal disease (ESRD; CL CR = 8.1 ± 9.1 mL/min) and who received a single intravenous infusion of metronidazole 500 mg had no significant change in metronidazole pharmacokinetics but had 2 fold higher C max of hydroxy-metronidazole and 5 fold higher C max of metronidazole acetate, compared to healthy subjects with normal renal function (CL CR = 126 ± 16 mL/min). Thus, on account of the potential accumulation of metronidazole metabolites in ESRD patients, monitoring for metronidazole associated adverse events is recommended (see PRECAUTIONS ).

Effect of Dialysis Following a single intravenous infusion or oral dose of metronidazole 500 mg, the clearance of metronidazole was investigated in ESRD subjects undergoing hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). A hemodialysis session lasting for 4 to 8 hours removed 40% to 65% of the administered metronidazole dose, depending on the type of dialyzer membrane used and the duration of the dialysis session. If the administration of metronidazole cannot be separated from the dialysis session, supplementation of metronidazole dose following hemodialysis should be considered (see DOSAGE AND ADMINISTRATION ).

A peritoneal dialysis session lasting for 7.5 hours removed approximately 10% of the administered metronidazole dose. No adjustment in metronidazole dose is needed in ESRD patients undergoing CAPD. Hepatic Impairment Following a single intravenous infusion of 500 mg metronidazole, the mean AUC 24 of metronidazole was higher by 114% in patients with severe (Child-Pugh C) hepatic impairment, and by 54% and 53% in patients with mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment, respectively, compared to healthy control subjects.

There were no significant changes in the AUC 24 of hydroxyl-metronidazole in these hepatically impaired patients. A reduction in metronidazole dosage by 50% is recommended in patients with severe (Child-Pugh C) hepatic impairment (see DOSAGE AND ADMINISTRATION ). No dosage adjustme…

📦 How Supplied / Storage and Handling 198 words ▾

HOW SUPPLIED Metronidazole Tablets USP are available as follows: 500 mg - White, oblong, convex tablets debossed “ PLIVA 334 ” on one side and unscored on the other side. Available in bottles of 4, 14, 21, 28, and 30. Storage and Stability Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

PROTECT FROM LIGHT Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. REFERENCES 1.

Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard -Eighth Edition . CLSI document M11-A8.

Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA, 2012. 2. Clinical and Laboratory Standards Institute (CLSI).

Performance Standards for Antimicrobial Susceptibility Testing; Twenty-third Informational Supplement , CLSI document M100-S23. CLSI document M100-S23, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2013. Manufactured In Czech Republic By: TEVA CZECH INDUSTRIES s.r.o.

Opava-Komarov, Czech Republic Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Rev. B 9/2013

📋 Description 61 words ▾

DESCRIPTION Metronidazole, USP is an oral synthetic antiprotozoal and antibacterial agent, 1 H -Imidazole-1-ethanol, 2-methyl-5-nitro, which has the following structural formula: C 6 H 9 N 3 O 3 M.W. 171.15 Each tablet for oral administration contains 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and hydrogenated vegetable oil. structural formula

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63187-0032-06 · Proficient 63187-0036-20 · Proficient →
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.