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Metronidazole 7.5 mg/g Cream — NDC 59651-0770-46 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Metronidazole 7.5 mg/g Cream — NDC 59651-770-46 (Billing 59651-0770-46)

by Aurobindo Pharma Limited · 1 TUBE in 1 CARTON / 45 g in 1 TUBE

This is a package of Metronidazole 7.5 mg/g Cream from Aurobindo Pharma Limited, marketed since Jul 2025 and currently FDA-listed; retail pharmacies pay about $0.2571 per g (NADAC). It is this product's only package size.

NDC 59651-0770-46
🏷️ FDA NDC (as labeled) 59651-770-46 billing pads the product segment with a zero
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 59651-770-46 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59651 labeler · 770 product · 46 package
Package marketed since
Jul 9, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0359651770467
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59651-770-46
Product NDC 59651-770
11-digit billing NDC 59651077046
NCPDP billing unit GM — per gram (weight)
RxCUI 311678
UNII 140QMO216E
UPC 0359651770467
Application # ANDA219295
SPL Set ID 0b6f6fbd-0292-4c48-a4ae-c24b5f0c8f74
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 2025-07-09
Route TOPICAL
Dosage form CREAM
Substance METRONIDAZOLE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 90060040003710
GCN Seq No 041799
GCN 43203
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 0.75% CREAM
FDB brand name Metronidazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 041799
  • GCN: 43203
  • GPI-14 (Medi-Span): 90060040003710
  • HICL (First Databank): 004157
  • AHFS class code: 08:30.04.00
  • RxCUI (RxNorm): 311678
Why two NDCs? The FDA registers this code as 59651-770-46 — 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 → 59651-0770-46. 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 0.75% CREAM 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 $0.257 $11.57 / 45 g
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 $0.6934 $31.20 / 45 g
NADAC price history (per g) — tap or hover for the price & month
Apr 2026 May 2026 Jul 2026 Sep 2026 $0.301 $0.257
▼ Down 15% over the last 6 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 Marketing startMarketing endStatus
59651-0770-46 You're viewing this Main listing 1 TUBE in 1 CARTON / 45 g in 1 TUBE 2025-07-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metronidazole 7.5 mg/g 00713-0637-37 Cosette 1 tube $0.179 AB Availability likely save 30%
Metronidazole 7.5 mg/g 72578-0209-04 Viona 1 tube $0.179 AB Availability likely save 30%
Metronidazole 7.5 mg/g 00168-0323-46 Fougera 45 g $0.257 AB Availability likely —
Metronidazole 7.5 mg/g 00713-0633-37 Cosette 1 tube $0.257 AB Availability likely —
Metronidazole 7.5 mg/gthis 59651-0770-46 Aurobindo 1 tube $0.257 AB Availability likely —
Metronidazole 7.5 mg/g 66993-0960-45 Prasco 1 tube $0.257 AB Availability likely —
Metronidazole 7.5 mg/g 68308-0711-45 Mayne 1 tube $0.257 AB Availability likely —
Metronidazole 7.5 mg/g 72578-0129-08 Viona 1 tube $0.257 BX Availability likely —
metronidazole 7.5 mg/g 68308-0712-59 Mayne 1 bottle $1.817 AB Availability likely +607%
Metronidazole 7.5 mg/g 68788-8552-04 Preferred 1 tube — BX FDA listed —
Metronidazole 7.5 mg/g 70771-1834-04 Zydus 1 tube — BX FDA listed —
Metronidazole 7.5 mg/g 72162-2259-02 Bryant 45 g — AB FDA listed —
Metronidazole 7.5 mg/g 51672-4116-02 Sun 1 tube — AB FDA listed —
Metronidazole 7.5 mg/g 70771-1978-04 Zydus 1 tube — AB FDA listed —
Metronidazole 7.5 mg/g 67296-2121-04 Redpharm 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
Jul 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.

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

  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 8CRQ2TH63M
    Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • 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.

7 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

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA219295 (ANDA)
Labeler code59651
First marketedJul 2025
Product typeHuman Prescription Drug
Portfolio1,456 products on file

More NDCs from Aurobindo Pharma Limited labeler code 59651

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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

INDICATIONS AND USAGE: Metronidazole topical cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

⏱️ Dosage and Administration 48 words ▾

DOSAGE AND ADMINISTRATION: Apply and rub in a thin layer of metronidazole topical cream twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of metronidazole topical cream.

⛔ Contraindications 21 words ▾

CONTRAINDICATIONS: Metronidazole topical cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.

🤒 Adverse Reactions 98 words ▾

ADVERSE REACTIONS: In controlled clinical trials, the total incidence of adverse reactions associated with the use of metronidazole topical cream was approximately 10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients.

The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea. To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 35 words ▾

Drug Interactions: Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

🤰 Pregnancy 79 words ▾

Pregnancy: Teratogenic effects: There are no adequate and well-controlled studies with the use of metronidazole topical cream in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice.

However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 12 words ▾

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

🧬 Clinical Pharmacology 22 words ▾

CLINICAL PHARMACOLOGY: The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

📦 How Supplied / Storage and Handling 65 words ▾

HOW SUPPLIED: Metronidazole Topical Cream, 0.75% is supplied in a: 45 g aluminum tube NDC 59651-770-46 Storage conditions : Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: March 2025

📋 Description 95 words ▾

DESCRIPTION: Metronidazole topical cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, lactic acid and sodium hydroxide to adjust pH, purified water and sorbitol solution. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1 H -imidazole-1-ethanol.

The molecular formula is C 6 H 9 N 3 O 3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula: str

💬 Information for Patients 25 words ▾

Information for patients: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS: General: Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use.

Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia. Information for patients: This medication is to be used as directed by the physician. It is for external use only.

Avoid contact with the eyes. Drug Interactions: Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

Carcinogenesis, mutagenesis, impairment of fertility: Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters. Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn’s disease who were treated with 200 to 1200 mg/day of metronidazole for 1 to 24 months.

However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months. Pregnancy: Teratogenic effects: There are no adequate and well-controlled studies with the use of metronidazole topical cream in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly.

No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed. Nursing mothers: After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma.

Even though blood levels are significantly lower with topically applied metronidazole than those achieved after oral administration of metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric use: Safety and effectiveness in pediatric patients have not been established.

🍼 Nursing Mothers 64 words ▾

Nursing mothers: After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels are significantly lower with topically applied metronidazole than those achieved after oral administration of metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 109 words ▾

Carcinogenesis, mutagenesis, impairment of fertility: Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters. Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn’s disease who were treated with 200 to 1200 mg/day of metronidazole for 1 to 24 months.

However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.

📄 Package Label / Principal Display Panel 78 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Label NDC 59651-770-46 Rx only Metronidazole Topical Cream 0.75% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO NET WT. 45 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Carton NDC 59651-770-46 Rx only Metronidazole Topical Cream 0.75% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO NET WT. 45 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

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.
← 59651-0769-37 · Aurobindo 59651-0771-37 · Aurobindo →
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.