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Metronidazole 10 mg/g Gel — NDC 46708-0630-55 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 46708-630-55 (Billing 46708-0630-55)

by Alembic Pharmaceuticals Limited · 1 BOTTLE, PUMP in 1 CARTON / 55 g in 1 BOTTLE, PUMP

This is a package of Metronidazole 10 mg/g Gel from Alembic Pharmaceuticals Limited, marketed since Mar 2025 and currently FDA-listed.

NDC 46708-0630-55
🏷️ FDA NDC (as labeled) 46708-630-55 billing pads the product segment with a zero
This package
Contains55 g in 1 bottle, pump Pack sizes3 compare ↓
Also priced by: Part D plans $1.40/unit — full pricing hub ↓
Product page 46708-0630-45 Also comes in: 45 g 46708-630-45 60 g 46708-630-60
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 46708-630-55 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
46708 labeler · 630 product · 55 package
Package marketed since
Mar 17, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0346708630607
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 46708-630-55
Product NDC 46708-630
11-digit billing NDC 46708063055
RxCUI 577237
UNII 140QMO216E
UPC 0346708630607
Application # ANDA212646
SPL Set ID e43b880b-ce69-4f56-9c1c-9c7ca23bba84
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 2025-03-17
Route TOPICAL
Dosage form GEL
Substance METRONIDAZOLE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 577237
Why two NDCs? The FDA registers this code as 46708-630-55 — 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 → 46708-0630-55. 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

📗 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 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 $1.40 $76.73 / 55 g
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 Marketing startMarketing endStatus
46708-0630-45 46708-630-45 Main listing 1 TUBE in 1 CARTON / 45 g in 1 TUBE 2025-03-17 — Active
46708-0630-55 You're viewing this 1 BOTTLE, PUMP in 1 CARTON / 55 g in 1 BOTTLE, PUMP 2025-03-17 — Active
46708-0630-60 46708-630-60 1 TUBE in 1 CARTON / 60 g in 1 TUBE 2025-03-17 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, pump in 1 carton / 55 g in 1 bottle, pump.
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metronidazole 10 mg/g 68308-0663-55 Mayne 1 bottle $0.540 AB Availability likely —
Metronidazole 10 mg/g 00713-0574-60 Cosette 1 tube $0.621 AB Availability likely —
Metronidazole 10 mg/g 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 —
metronidazole 10 mg/g 66993-0936-58 Prasco 55 g $0.866 AB Discontinued —
Metronidazole 10 mg/gthis 46708-0630-55 Alembic 1 bottle — 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

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year 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.

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 JV039JZZ3A
    Betadex is a modified sugar molecule derived from starch. It acts as a solubilizer and stabilizer in medicines, helping dissolve poorly soluble drugs and keep them stable during storage.
  • 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 ZYD53NBL45
    Hydroxyethyl cellulose is a plant-based thickening agent derived from cellulose. It helps control the texture and consistency of liquid or semi-solid medicines, and may also help keep ingredients evenly mixed throughout the product.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety 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.

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.

Manufacturer & labeler

LabelerAlembic Pharmaceuticals Limited
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA212646 (ANDA)
Labeler code46708
First marketedMar 2025
Product typeHuman Prescription Drug
Portfolio502 products on file

More NDCs from Alembic Pharmaceuticals Limited labeler code 46708

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 📋 Description 💬 Information for Patients 💬 Patient Medication Information 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

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

⏱️ Dosage and Administration 102 words ▾

2 DOSAGE AND ADMINISTRATION 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.

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

( 2 ) Not for oral, ophthalmic or intravaginal use. ( 2 )

💊 Dosage Forms and Strengths 33 words ▾

3 DOSAGE FORMS AND STRENGTHS Gel, 1%. Metronidazole gel USP is a clear, colorless to pale yellow gel. Each gram of metronidazole gel USP contains 10 mg (1%) of metronidazole USP. 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. Immediate reevaluate Metronidazole gel therapy if abnormal neurologic signs appear.

( 5.1 ) Blood Dyscrasias: Metronidazole gel is a nitroimidazole; use 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.

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. Immediately reevaluate metronidazole gel therapy if abnormal neurologic signs appear. Administer metronidazole with caution to patients with central nervous system diseases.

5.2Blood Dyscrasias Metronidazole gel 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 The following clinically significant adverse reactions are described elsewhere in the labeling: ● Neurologic Disease [see Warnings and Precautions (5.1)] ● Contact Dermatitis [see Warnings and Precautions (5.3)] ● Eye Irritation [see Warnings and Precautions (5.4)] Most common adverse reactions (incidence > 2%) are nasopharyngitis, upper respiratory tract infection, and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact 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, 1% 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% and at a higher rate than vehicle: Table 1: Adverse Reactions That Occurred at a Rate of ≥1% and Higher Than Vehicle in Subjects Treated with metronidazole gel for Up to 10 Weeks Preferred Term Metronidazole Gel, 1% Vehicle (N= 557) N (%) (N= 189) N (%) Influenza 8 (1.4) 1 (0.5) Upper respiratory tract infection 14 (2.5) 4 (2.1) Urinary tract infection 6 (1.1) 1 (0.5) Headache 12 (2.2) 1 (0.5) Contact dermatitis 7 (1.3) 1 (0.5) Hypertension 6 (1.1) 1 (0.5) Table 2: Local Cutaneous Signs and Symptoms of Irritation That Were Worse Than Baseline in Subjects Treated with metronidazole gel for Up to 10 Weeks Metronidazole Gel, 1% Vehicle Sign/Symptom (N= 544) N (%) (N= 184) N (%) 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 reactions 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 Ophthalmic Adverse Reactions: Tearing of the eyes

🔄 Drug Interactions 73 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. Use caution when prescribing for patients who are receiving anticoagulant treatment. 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 between 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 gel.

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 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 of metronidazole gel have not been established in pediatric patients.

8.5Geriatric Use Sixty-six subjects aged 65 years and older were treated with metronidazole gel, 1% 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 136 words ▾

8.1Pregnancy Risk Summary Available data have not established an association between 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 gel.

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 16 words ▾

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

🧓 Geriatric Use 63 words ▾

8.5Geriatric Use Sixty-six subjects aged 65 years and older were treated with metronidazole gel, 1% 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 150 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 gel 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 to 24) was 595 ± 154 ng*hr/mL. The mean C max and AUC (0 to 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 63 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Metronidazole gel USP, 1% is clear, colorless to pale yellow in color, and supplied as follows: 45 gram tube- NDC 46708-630-45 60 gram tube- NDC 46708-630-60 55 gram pump- NDC 46708-630-55 Storage and Handling Store at 20˚ to 25˚C (68˚ to 77˚F); excursions permitted between 15˚ to 30˚C (59˚ to 86˚F) [see USP controlled room temperature].

📋 Description 118 words ▾

11 DESCRIPTION Metronidazole gel USP, 1% is a nitroimidazole for topical use. Metronidazole gel USP, 1% is a clear, colorless to pale yellow, aqueous gel. Each gram contains 10 mg of metronidazole.

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.

The inactive ingredients are betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water. Image

💬 Information for Patients 109 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 [see Warnings and Precautions (5.4)].

Cleanse treated areas before the application of metronidazole gel [see Dosage and Administration (2)] Advise patients to report any adverse reaction to their healthcare providers. Neurologic Disease Advise patients to immediately report any abnormal neurologic signs to their healthcare provider [see Warnings and Precautions (5.1)]. Lactation Advise women not to breastfeed during treatment with metronidazole gel [see Use in Specific Populations (8.2)].

Rx Only Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION PATIENT INFORMATION Metronidazole (MET-roe-NYE-da-zole) Gel, USP 1% 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 at 1-866-210-9797. 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 healthcare provider for information about metronidazole gel that is written for health professionals. What are the ingred… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 63 words ▾

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 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.

🧬 Pharmacokinetics 99 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 to 24) was 595 ± 154 ng*hr/mL. The mean C max and AUC (0 to 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 31 words ▾

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

🔬 Clinical Studies 210 words ▾

14 CLINICAL STUDIES In a randomized, vehicle-controlled trial, 746 subjects with rosacea were treated with metronidazole gel,1% 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 Subjects with Rosacea at Week 10 in a Clinical Trial Metronidazole Gel, 1% 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, 1% 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.

🧪 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.

📄 Package Label / Principal Display Panel 124 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Metronidazole Gel USP, 1% For Topical Use Only NDC 46708-630-60 Rx Only 60 grams For topical use only. Not for oral, ophthalmic or intravaginal use. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep out of reach of children. Usual dosage: Apply a thin film once a day to affected areas. See prescribing information for complete instructions.

Each gram contains: 10 mg (1%) metronidazole USP, as active ingredient in a gel base consisting of betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben, and purified water. Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg.

License No.: G/25/2216 label carton label

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

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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Alembic Pharmaceuticals Limited. 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 2 other package presentations of this same product, including 1 tube (46708-0630-45), 1 tube (46708-0630-60). 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?
Alembic Pharmaceuticals Limited 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.
← 46708-0625-02 · Alembic 46708-0632-15 · Alembic →
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.