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Metronidazole 10 mg/g Gel — NDC 51672-4215-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Metronidazole 10 mg/g Gel — NDC 51672-4215-3 (Billing 51672-4215-03)

by Sun Pharmaceutical Industries, Inc. · 1 TUBE in 1 CARTON / 60 g in 1 TUBE

This is a package of Metronidazole 10 mg/g Gel from Sun Pharmaceutical Industries, Inc., marketed since Apr 2019 and currently FDA-listed; retail pharmacies pay about $0.6210 per g (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 51672-4215-03
🏷️ FDA NDC (as labeled) 51672-4215-3 billing pads the package segment with a zero
This package
Contains60 g in 1 tube Cost per g$0.6210 NADAC Per package$37.26 / 60 g Pack sizes3 compare ↓
Also priced by: Medicaid pays $1.00/unit · Part D plans $1.40/unit — full pricing hub ↓
Main listing for product 51672-4215 · Also comes in: 45 g 51672-4215-6 55 g 51672-4215-9
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 51672-4215-3 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
51672 labeler · 4215 product · 3 package
Package marketed since
Apr 9, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5167242153 3
Medicaid fills, this package
12,470 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51672-4215-3
Product NDC 51672-4215
11-digit billing NDC 51672421503
NCPDP billing unit GM — per gram (weight)
RxCUI 577237
UNII 140QMO216E
Application # ANDA204651
SPL Set ID 5842a554-58d1-4ee4-99aa-1e6029a69be2
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 2019-04-09
Route TOPICAL
Dosage form GEL
Substance METRONIDAZOLE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 059325
GCN 24926
HICL code 004157
Ingredient (HICL) Metronidazole
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5G
Therapeutic class — specific (HIC3) Rosacea Agents, Topical
AHFS code 08:30.04.00
AHFS class Amebicides
FDB label name METRONIDAZOLE TOPICAL 1% GEL
FDB brand name Metronidazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 059325
  • GCN: 24926
  • HICL (First Databank): 004157
  • AHFS class code: 08:30.04.00
  • RxCUI (RxNorm): 577237
Why two NDCs? The FDA registers this code as 51672-4215-3 — a 5-4-1 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 package segment → 51672-4215-03. 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.

Clinical

Label name METRONIDAZOLE TOPICAL 1% GEL Ingredient Metronidazole
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Oral forms treat trichomoniasis, and some also treat amebiasis and anaerobic infections. Vaginal gels treat bacterial vaginosis, and topical cream or lot...
  • No. Alcohol with oral metronidazole can cause cramps, nausea, vomiting, headache and flushing. Avoid alcohol and products with propylene glycol during treatment and for at least th...
  • The most common are nausea, headache, loss of appetite, vomiting, diarrhea and stomach cramps. A metallic taste is also common. Call your doctor if you notice numbness or tingling,...
  • Yes. Metronidazole can interact with warfarin, lithium, busulfan, disulfiram and drugs that affect heart rhythm. Some of these combinations need blood tests or should be avoided, s...
📖 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.

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 gPer package
Retail pharmacies payNADAC · weekly $0.621 $37.26 / 60 g
Medicaid paysCMS SDUD · 12 mo $1.00 $60.18 / 60 g
Medicare drug plans payPart D · Q2 2026 $1.40 $83.70 / 60 g
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.347 $0.621
▼ Down 54% over the last 24 months.
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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
51672-4215-03 You're viewing this Main listing 1 TUBE in 1 CARTON / 60 g in 1 TUBE $0.6210 / g $37.26 2019-04-09 — Active
51672-4215-06 51672-4215-6 1 TUBE in 1 CARTON / 45 g in 1 TUBE — — 2019-04-09 — Active
51672-4215-09 51672-4215-9 1 BOTTLE, PUMP in 1 CARTON / 55 g in 1 BOTTLE, PUMP $0.5399 / g $29.69 2019-04-09 — Active

Per g, this pack runs about 15% above the cheapest pack (NDC 51672-4215-09, $0.5399 vs $0.6210 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 93% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 60 g in 1 tube.
What NDC number is used to bill for this package of Metronidazole 10 mg/g Gel?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metronidazole 10 mg/g 68308-0663-55 Mayne 1 bottle $0.540 AB Availability likely save 13%
Metronidazole 10 mg/g 00713-0574-60 Cosette 1 tube $0.621 AB Availability likely —
Metronidazole 10 mg/gthis 51672-4215-03 Sun 1 tube $0.621 AB Availability likely —
Metronidazole 10 mg/g 59651-0813-60 Aurobindo 1 tube $0.621 AB Availability likely —
Metronidazole 10 mg/g 51672-4164-03 Sun 1 tube $0.672 AB Discontinued +8%
metronidazole 10 mg/g 66993-0936-58 Prasco 55 g $0.866 AB Discontinued +39%
Metronidazole 10 mg/g 46708-0630-45 Alembic 1 tube — AB FDA listed —
Metronidazole 10 mg/g 62332-0630-45 Alembic 1 tube — 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

🏛️
2019
On the market since
Apr 2019
📍
2026
Currently FDA-listed
7 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.

What it looks like

Color yellow
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.

🧪 Avoiding an ingredient? See Metronidazole inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • 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.

6 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.

Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
Application holderTARO PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA204651 (ANDA)
Labeler code51672
First marketedApr 2019
Product typeHuman Prescription Drug
Portfolio890 products on file

More NDCs from Sun Pharmaceutical Industries, Inc. labeler code 51672

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 words ▾

1 INDICATIONS AND USAGE Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. Metronidazole gel is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. ( 1 )

⏱️ Dosage and Administration 99 words ▾

2 DOSAGE AND ADMINISTRATION For topical use only, not for oral, ophthalmic, or intravaginal use. Cleanse treated areas before the application of metronidazole gel. Apply and rub in a thin film of metronidazole gel once daily to affected area(s).

Cosmetics may be applied after the application of metronidazole gel. Not for oral, ophthalmic, or intravaginal use. ( 2 ) Cleanse treated areas before the application of metronidazole.

( 2 ) Apply and rub in a thin film of metronidazole once daily to affected area(s). ( 2 ) Cosmetics may be applied after the application of metronidazole. ( 2 )

💊 Dosage Forms and Strengths 28 words ▾

3 DOSAGE FORMS AND STRENGTHS Gel, 1%. Metronidazole is a colorless to slightly yellow gel. Each gram of metronidazole gel contains 10 mg (1%) of metronidazole. Gel, 1%.

⛔ Contraindications 48 words ▾

4 CONTRAINDICATIONS Metronidazole gel is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation. Metronidazole gel is contraindicated in those patients with a history of hypersensitivity to metronidazole or to any other ingredient in this formulation. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Neurologic Disease: Peripheral neuropathy, characterized by numbness or paresthesia of an extremity has been reported in patients treated with systemic metronidazole. Peripheral neuropathy has been reported with the post approval use of topical metronidazole. The appearance of abnormal neurologic signs should prompt immediate reevaluation of metronidazole therapy.

( 5.1 ) Blood Dyscrasias: Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia. ( 5.2 ) Contact Dermatitis: If dermatitis occurs, patients may need to discontinue use. ( 5.3 ) Eye Irritation: Topical metronidazole has been reported to cause tearing of the eyes.

Therefore, avoid contact with the eyes. ( 5.4 )

5.1Neurologic Disease Peripheral neuropathy, characterized by numbness or paresthesia of an extremity, has been reported in patients treated with systemic metronidazole. Peripheral neuropathy has been reported with the post approval use of topical metronidazole. The appearance of abnormal neurologic signs should prompt immediate reevaluation of metronidazole therapy.

Metronidazole should be administered with caution to patients with central nervous system diseases.

5.2Blood Dyscrasias Metronidazole is a nitroimidazole; use with care in patients with evidence of, or history of, blood dyscrasia.

5.3Contact Dermatitis Irritant and allergic contact dermatitis have been reported with metronidazole gel. If dermatitis occurs, patients may need to discontinue use.

5.4Eye Irritation Topical metronidazole has been reported to cause tearing of the eyes. Avoid contact with the eyes.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (incidence > 2%) are nasopharyngitis, upper respiratory tract infection, and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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. In a controlled clinical trial, 557 subjects used metronidazole gel and 189 subjects used the gel vehicle once daily for up to 10 weeks. The following table summarizes selected adverse reactions that occurred at a rate of ≥1%: Table 1: Adverse Reactions That Occurred at a Rate of ≥1% System Organ Class/Preferred Term Metronidazole Gel Vehicle N=557 N=189 Patients with at least one AE Number (%) of Patients 186 (33.4) 51 (27.0) Infections and infestations 76 (13.6) 28 (14.8) Bronchitis 6 (1.1) 3 (1.6) Influenza 8 (1.4) 1 (0.5) Nasopharyngitis 17 (3.1) 8 (4.2) Sinusitis 8 (1.4) 3 (1.6) Upper respiratory tract infection 14 (2.5) 4 (2.1) Urinary tract infection 6 (1.1) 1 (0.5) Vaginal mycosis 1 (0.2) 2 (1.1) Musculoskeletal and connective tissue disorders 19 (3.4) 5 (2.6) Back pain 3 (0.5) 2 (1.1) Neoplasms 4 (0.7) 2 (1.1) Basal cell carcinoma 1 (0.2) 2 (1.1) Nervous system disorders 18 (3.2) 3 (1.6) Headache 12 (2.2) 1 (0.5) Respiratory, thoracic and mediastinal disorders 22 (3.9) 5 (2.6) Nasal congestion 6 (1.1) 3 (1.6) Skin and subcutaneous tissue disorders 36 (6.5) 12 (6.3) Contact dermatitis 7 (1.3) 1 (0.5) Dry skin 6 (1.1) 3 (1.6) Vascular disorders 8 (1.4) 1 (0.5) Hypertension 6 (1.1) 1 (0.5) Table 2: Local Cutaneous Signs and Symptoms of Irritation That Were Worse Than Baseline Metronidazole Gel Vehicle Sign/Symptom N=544 N=184 Dryness 138 (25.4) 63 (34.2) Mild 93 (17.1) 41 (22.3) Moderate 42 (7.7) 20 (10.9) Severe 3 (0.6) 2 (1.1) Scaling 134 (24.6) 60 (32.6) Mild 88 (16.2) 32 (17.4) Moderate 43 (7.9) 27 (14.7) Severe 3 (0.6) 1 (0.5) Pruritus 86 (15.8) 35 (19.0) Mild 53 (9.7) 21 (11.4) Moderate 27 (5.0) 13 (7.1) Severe 6 (1.1) 1 (0.5) Stinging/burning 56 (10.3) 28 (15.2) Mild 39 (7.2) 18 (9.8) Moderate 7 (1.3) 9 (4.9) Severe 10 (1.8) 1 (0.5) The following additional adverse experiences have been reported with the topical use of metronidazole: transient redness, metallic taste, tingling or numbness of extremities, and nausea.

6.2Post Marketing Experience The following adverse reaction has been identified during post-approval use of topical metronidazole. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure. Nervous System Disorders: Peripheral neuropathy [see Warnings and Precautions (5.1) ]

🔄 Drug Interactions 95 words ▾

7 DRUG INTERACTIONS Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when metronidazole is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption. Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time.

Use caution when administering metronidazole gel concomitantly to patients who are receiving anticoagulant treatment. ( 7 )

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended. ( 8.2 )

8.1Pregnancy Risk Summary Available data have not established an association with metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. No fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. The available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of metronidazole.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary It is not known whether metronidazole is present in human milk after topical administration. Published literature reports the presence of metronidazole in human milk after oral administration. There are reports of diarrhea and candida infection in breastfed infants of mothers receiving oral treatment with metronidazole.

There are no data on the effects of metronidazole on milk production. Because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with metronidazole gel.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use Sixty-six subjects aged 65 years and older were treated with metronidazole gel in the clinical study. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🤰 Pregnancy 135 words ▾

8.1Pregnancy Risk Summary Available data have not established an association with metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. No fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. The available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of metronidazole.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 62 words ▾

8.5Geriatric Use Sixty-six subjects aged 65 years and older were treated with metronidazole gel in the clinical study. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology 144 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of metronidazole in the treatment of rosacea is unknown.

12.2Pharmacodynamics The pharmacodynamics of metronidazole in association with the treatment of rosacea are unknown. Cardiac Electrophysiology: The effect of metronidazole on the QTc interval has not been adequately characterized.

12.3Pharmacokinetics Topical administration of a one-gram dose of metronidazole gel to the face of 13 subjects with moderate to severe rosacea once daily for 7 days resulted in a mean ± SD C max of metronidazole of 32 ± 9 ng/mL. The mean ± SD AUC (0-24) was 595 ± 154 ng*hr/mL. The mean C max and AUC (0-24) are less than 1% of the value reported for a single 250 mg oral dose of metronidazole.

The time to maximum plasma concentration (T max ) was 6 to 10 hours after topical application.

🧬 Mechanism of Action 17 words ▾

12.1Mechanism of Action The mechanism of action of metronidazole in the treatment of rosacea is unknown.

📦 How Supplied / Storage and Handling 60 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Metronidazole Gel USP, 1% is colorless to slightly yellow in color, and supplied as follows: 45 gram tube - (NDC 51672-4215-6) 60 gram tube - (NDC 51672-4215-3) 55 gram pump - (NDC 51672-4215-9)

16.2Storage and Handling Storage Conditions: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 19 words ▾

16.2Storage and Handling Storage Conditions: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 119 words ▾

11 DESCRIPTION Metronidazole Gel USP, 1% contains metronidazole, USP. It is intended for topical use. Chemically, metronidazole is 2-methyl-5-nitro-1 H -imidazole-1-ethanol.

The molecular formula for metronidazole is C 6 H 9 N 3 O 3 . It has the following structural formula: Metronidazole has a molecular weight of 171.16. It is a white to pale yellow crystalline powder.

It is slightly soluble in alcohol and has solubility in water of 10 mg/mL at 20°C. Metronidazole belongs to the nitroimidazole class of compounds. Metronidazole is a colorless to slightly yellow gel; each gram contains 10 mg of metronidazole in a base of alcohol (9.3% w/w), edetate disodium, hydroxyethylcellulose, polyethylene glycol 400, propylene glycol, sorbic acid, and purified water.

Chemical Structure

💬 Information for Patients 64 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Administration Instructions Use as directed. Avoid contact with the eyes. Cleanse treated areas before the application of metronidazole gel. Advise patients to report any adverse reaction to their healthcare providers. Lactation Advise women not to breastfeed during treatment with metronidazole gel [see Use in Specific Populations (8.2) ] .

🧬 Pharmacokinetics 94 words ▾

12.3Pharmacokinetics Topical administration of a one-gram dose of metronidazole gel to the face of 13 subjects with moderate to severe rosacea once daily for 7 days resulted in a mean ± SD C max of metronidazole of 32 ± 9 ng/mL. The mean ± SD AUC (0-24) was 595 ± 154 ng*hr/mL. The mean C max and AUC (0-24) are less than 1% of the value reported for a single 250 mg oral dose of metronidazole.

The time to maximum plasma concentration (T max ) was 6 to 10 hours after topical application.

🧬 Pharmacodynamics 30 words ▾

12.2Pharmacodynamics The pharmacodynamics of metronidazole in association with the treatment of rosacea are unknown. Cardiac Electrophysiology: The effect of metronidazole on the QTc interval has not been adequately characterized.

🔬 Clinical Studies 217 words ▾

14 CLINICAL STUDIES In a randomized, vehicle-controlled trial, 746 subjects with rosacea were treated with metronidazole gel or vehicle once daily for 10 weeks. Most subjects had a disease severity score of 3 ("moderate") on the 5-point Investigator Global Assessment (IGA) scale, with 8 to 50 inflammatory lesions and no more than two nodules at baseline. The co-primary efficacy endpoints were the percent reduction in inflammatory lesion counts and percentage of subjects with success on IGA, defined as an IGA score of 0 ("clear") or 1 ("almost clear") at Week 10.

The efficacy results are shown in the following table: Table 3: Inflammatory Lesion Counts and Global Scores in a Clinical Trial of Rosacea Metronidazole Gel Vehicle N Results N (%) N Results N (%) Inflammatory lesions 557 189 Baseline, mean count 18.3

18.4Week-10, mean count 8.9

12.8Reduction 9.4 (50.7) 5.6 (32.6) Investigator Global Assessment 557 189 Subject clear or almost clear 214 (38.42) 52 (27.51) Subject with no change 159 (28.5) 77 (40.7) Subjects treated with metronidazole gel experienced a mean reduction of 9.4 inflammatory lesions in the Week-10 LOCF group, compared to a reduction of 5.6 for those treated with vehicle, or a difference in means of 3.8 lesions. The contribution to efficacy of individual components of the vehicle has not been established.

🧪 Nonclinical Toxicology 169 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Metronidazole has shown evidence of carcinogenic activity in studies involving chronic oral administration in mice and rats, but not in studies involving hamsters. In several long-term studies in mice, oral doses of approximately 225 mg/m 2 /day or greater were associated with an increase in pulmonary tumors and lymphomas. Several long-term oral studies in the rat have shown statistically significant increases in mammary and hepatic tumors at doses >885 mg/m 2 /day.

Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-related increase in the frequency of micronuclei was observed in mice after intraperitoneal injections. An increase in chromosomal aberrations in peripheral blood lymphocytes was reported in patients with Crohn's disease who were treated with 200 to 1200 mg/day of metronidazole for 1 to 24 months.

However, in another study, no increase in chromosomal aberrations in circulating lymphocytes was observed in patients with Crohn's disease treated with the drug for 8 months.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 166 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Metronidazole has shown evidence of carcinogenic activity in studies involving chronic oral administration in mice and rats, but not in studies involving hamsters. In several long-term studies in mice, oral doses of approximately 225 mg/m 2 /day or greater were associated with an increase in pulmonary tumors and lymphomas. Several long-term oral studies in the rat have shown statistically significant increases in mammary and hepatic tumors at doses >885 mg/m 2 /day.

Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-related increase in the frequency of micronuclei was observed in mice after intraperitoneal injections. An increase in chromosomal aberrations in peripheral blood lymphocytes was reported in patients with Crohn's disease who were treated with 200 to 1200 mg/day of metronidazole for 1 to 24 months.

However, in another study, no increase in chromosomal aberrations in circulating lymphocytes was observed in patients with Crohn's disease treated with the drug for 8 months.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Metronidazole (me troe ni⸍ da zole) Gel, 1% This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: December 2022 Important: Metronidazole gel is for use on the skin only (topical use).

Do not use metronidazole gel in your mouth, eyes, or vagina. What is metronidazole gel? Metronidazole gel is a prescription medicine used on the skin (topical) to treat pimples and bumps (inflammatory lesions) caused by a condition called rosacea.

It is not known if metronidazole gel is safe and effective in children. Do not use metronidazole gel if you are allergic to metronidazole or any of the ingredients in metronidazole gel. See the end of this leaflet for a complete list of ingredients in metronidazole gel.

Before using metronidazole gel, tell your healthcare provider about all your medical conditions, including if you: have tingling or numbness in your hands or feet have or have had a blood disorder or disease are pregnant or plan to become pregnant. It is not known if metronidazole gel will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if metronidazole gel passes into your breast milk.

Do not breastfeed during treatment with metronidazole gel. Talk to your healthcare provider about the best way to feed your baby during treatment with metronidazole gel. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use metronidazole gel?

Use metronidazole gel exactly as your healthcare provider tells you to. Cleanse the treated area before applying metronidazole gel. Apply and rub in a thin film of metronidazole gel 1 time a day to the affected area(s).

You can apply cosmetics after applying metronidazole gel. Avoid contact of metronidazole gel with your eyes. What are the possible side effects of metronidazole gel?

Metronidazole gel may cause serious side effects, including: Peripheral neuropathy. Tingling, burning, pain or numbness in the hands or feet (peripheral neuropathy) have happened in people treated with metronidazole used on the skin. Tell your healthcare provider if you experience tingling, burning, pain or numbness in your hands or feet during treatment with metronidazole gel.

Skin reactions, including allergic reactions. Tell your healthcare provider if you develop any skin reactions, including rash, itching, redness, swelling, or blisters during treatment with metronidazole gel. Eye irritation.

Tearing from eye irritation has happened in people treated with metronidazole used on the skin. Tell your healthcare provider if you experience tearing, redness or discomfort of the eyes during treatment with metronidazole gel. The most common side effects of metronidazole gel include: sore throat and nasal congestion upper respiratory tract infections headache Tell your healthcare provider if you get any side effects during treatment with metronidazole gel.

These are not all of the possible side effects of metronidazole gel. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914. How should I store metronidazole gel? Store metronidazole gel at room temperature between 68°F to 77°F (20°C to 25°C).

Keep metronidazole gel and all medicines out of the reach of children. General information about the safe and effective use of metronidazole gel. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Do not use metronidazole gel for a condition for which it was not prescribed. Do not give metronidazole gel to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcar… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 42 words ▾

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton NDC 51672-4215-3 Metronidazole Gel USP, 1% 60 g FOR TOPICAL USE ONLY. NOT FOR ORAL, OPHTHALMIC OR INTRAVAGINAL USE. Rx only Keep this and all medications out of the reach of children. TARO metronidazole-02

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
12.5K
Units reimbursed last 4 qtrs
747.5K
Gross reimbursed last 4 qtrs
$749.7K
Avg / prescription
$60.12
Avg / unit
$1.0030
Latest quarter Q1 2026
2.5KRx
Medicaid pays / g
$1.0030
gross reimbursed
vs
NADAC / g
$0.6210
acquisition cost
=
Spread
+$0.3820
+62% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
29% FFS 71% MCO
Fee-for-service · 3,587 Rx Managed care · 8,883 Rx
State Medicaid map
Alaska: no data reported AK Maine: 6,600 units · 473 per 100k residents ME Washington: 19,260 units · 247 per 100k residents WA Idaho: 8,820 units · 449 per 100k residents ID Montana: 9,285 units · 820 per 100k residents MT North Dakota: no data reported ND Minnesota: 9,420 units · 164 per 100k residents MN Wisconsin: 24,840 units · 420 per 100k residents WI Michigan: 2,880 units · 28.7 per 100k residents MI New York: 67,975 units · 347 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,500 units · 107 per 100k residents NH Oregon: 660 units · 15.6 per 100k residents OR Nevada: 3,600 units · 113 per 100k residents NV Wyoming: no data reported WY South Dakota: 1,140 units · 124 per 100k residents SD Iowa: 5,580 units · 174 per 100k residents IA Illinois: 53,985 units · 430 per 100k residents IL Indiana: 20,460 units · 298 per 100k residents IN Ohio: 50,580 units · 429 per 100k residents OH Pennsylvania: 24,840 units · 192 per 100k residents PA New Jersey: 39,632 units · 427 per 100k residents NJ Massachusetts: 5,940 units · 84.8 per 100k residents MA California: 29,595 units · 76.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 4,920 units · 249 per 100k residents NE Missouri: 22,800 units · 368 per 100k residents MO Kentucky: 47,320 units · 1,046 per 100k residents KY West Virginia: no data reported WV Virginia: 32,370 units · 371 per 100k residents VA Maryland: 27,000 units · 437 per 100k residents MD Connecticut: 28,800 units · 796 per 100k residents CT Rhode Island: 3,360 units · 307 per 100k residents RI Arizona: 7,920 units · 107 per 100k residents AZ New Mexico: no data reported NM Kansas: 2,880 units · 98.0 per 100k residents KS Arkansas: no data reported AR Tennessee: 4,980 units · 69.9 per 100k residents TN North Carolina: 58,680 units · 542 per 100k residents NC South Carolina: 15,180 units · 283 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 23,520 units · 514 per 100k residents LA Mississippi: 720 units · 24.5 per 100k residents MS Alabama: no data reported AL Georgia: 3,840 units · 34.8 per 100k residents GA D.C.: 14,820 units · 2,183 per 100k residents DC Hawaii: no data reported HI Texas: 22,740 units · 74.6 per 100k residents TX Florida: 39,060 units · 173 per 100k residents FL
Units reimbursed · per 100k residents
15.62,183
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 D.C. 2,183 /100k
2 Kentucky 1,046 /100k
3 Montana 820 /100k
4 Connecticut 796 /100k
5 North Carolina 542 /100k
6 Louisiana 514 /100k
7 Maine 473 /100k
8 Idaho 449 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube this page51672-4215-03 12,470 Rx · $749,740
1 bottle51672-4215-09 939 Rx · $48,378
1 tube51672-4215-06 No Medicaid data
Drug total (last 4 qtrs): 13,409 Rx · 799,277 units · $798,117 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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.
← 51672-4209-02 · Sun 51672-4222-01 · Taro →
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.