Metronidazole 7.5 mg/g Gel
by Cosette Pharmaceuticals, Inc. · 1 TUBE in 1 CARTON (0713-0637-37) / 45 g in 1 TUBE
NDC 00713-0637-37
🏷️ FDA NDC (as labeled)
0713-0637-37
billing pads the labeler segment with a zero
Rx only
Generic
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
0713-0637-37
Product NDC
0713-0637
11-digit billing NDC
00713063737
NCPDP billing unit
GM — per gram (weight)
RxCUI
311679
UNII
140QMO216E
UPC
0307130637374
Application #
ANDA078178
SPL Set ID
86da8d86-5ab2-f668-fdfd-b0e93e6a2245
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
2011-04-01
Route
TOPICAL
Dosage form
GEL
Substance
METRONIDAZOLE
GPI-14
90060040004010
GPI class
metroNIDAZOLE
GCN Seq No
041798
GCN
43202
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 0.75% GL
FDB brand name
Metronidazole
Legend status
F — Federal legend — prescription drug or device
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 0713-0637-37 — a 4-4-2 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 labeler segment → 00713-0637-37. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️ RxNorm drug class
This medicine belongs to the Nitroimidazole Antimicrobial class.
Pharmacologic class
Nitroimidazole Antimicrobial
Drug family (ATC)
Nitroimidazole derivatives, Antiinfectives and antiseptics for local oral treatment, Other chemotherapeutics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerCosette Pharmaceuticals, Inc.
Application holderCOSETTE PHARMACEUTICALS NC LABORATORIES LLC
FDA applicationANDA078178 (ANDA)
Labeler code00713
First marketedApr 2011
Product typeHuman Prescription Drug
Portfolio99 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
Label name METRONIDAZOLE TOPICAL 0.75% GL Ingredient Metronidazole
📗 Our plain-language guide HelloPharmacist
- This is one of the most important things to know about metronidazole. If you drink alcohol — or consume products containing propylene glycol — while taking it, you can have a prett...
- Why do I have to avoid alcohol while taking this?
- Yes, completely normal and actually really important. Trichomoniasis is a sexually transmitted infection, so even if your partner has no symptoms, they can still carry the parasite...
- My partner and I both have to take this for trichomoniasis — is that normal?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Metronidazole — tap one for details:
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.
BIOTIN
Insignificant Depletion
FOLIC ACID
Insignificant Depletion
RIBOFLAVIN
Insignificant Depletion
THIAMINE
Insignificant Depletion
VITAMIN B12
Insignificant Depletion
+2 more
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.
💬 Questions about Metronidazole?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 4Q93RCW27E
A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
-
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 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 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 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 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.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.221 | $9.94 / 45 g |
| Medicaid paysCMS SDUD · 12 mo | $0.6510 | $29.30 / 45 g |
| Medicare drug plans payPart D · Q2 2026 | $0.7576 | $34.09 / 45 g |
NADAC price history (per g) — tap or hover for the price & month
▼ Down 61% 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Metronidazole 7.5 mg/gthis 00713-0637-37 | Cosette | 1 tube | $0.221 | AB | Availability likely | — |
| Metronidazole 7.5 mg/g 21922-0070-06 | Encube | 1 tube | $0.221 | AB | Availability likely | — |
| Metronidazole 7.5 mg/g 72578-0209-04 | Viona | 1 tube | $0.221 | AB | Availability likely | — |
| Metronidazole 7.5 mg/g 00713-0633-37 | Cosette | 1 tube | $0.268 | AB | Availability likely | +22% |
| Metronidazole 7.5 mg/g 68308-0711-45 | Mayne | 1 tube | $0.268 | AB | Availability likely | +22% |
| Metronidazole 7.5 mg/g 00168-0323-46 | Fougera | 45 g | $0.268 | AB | Availability likely | +22% |
| Metronidazole 7.5 mg/g 59651-0770-46 | Aurobindo | 1 tube | $0.268 | AB | Availability likely | +22% |
| Metronidazole 7.5 mg/g 66993-0960-45 | Prasco | 1 tube | $0.268 | AB | Availability likely | +22% |
| Metronidazole 7.5 mg/g 72578-0129-08 | Viona | 1 tube | $0.268 | BX | Availability likely | +22% |
| metronidazole 7.5 mg/g 68308-0712-59 | Mayne | 1 bottle | $1.792 | AB | Availability likely | +711% |
| Metronidazole 7.5 mg/g 51672-4116-02 | Sun | 1 tube | — | AB | FDA listed | — |
| Metronidazole 7.5 mg/g 67296-2121-04 | Redpharm | 1 tube | — | AB | FDA listed | — |
| Metronidazole 7.5 mg/g 70771-1978-04 | Zydus | 1 tube | — | AB | FDA listed | — |
| Metronidazole 7.5 mg/g 70771-1834-04 | Zydus | 1 tube | — | BX | FDA listed | — |
| Metronidazole 7.5 mg/g 68788-8552-04 | Preferred | 1 tube | — | BX | FDA listed | — |
| Metronidazole 7.5 mg/g 72162-2259-02 | Bryant | 45 g | — | 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
🏛️
2011
On the market since
Apr 2011
📍
2026
Currently FDA-listed
15 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.
🗺️ 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 00713-0637-37, 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 – Q4 2025 · 4 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
27.3K
Units reimbursed last 4 qtrs
1.2M
Gross reimbursed last 4 qtrs
$798.5K
Avg / prescription
$29.28
Avg / unit
$0.6510
Latest quarter Q4 2025
4.9KRx
Medicaid pays / g
$0.6510
gross reimbursed
vs
NADAC / g
$0.2209
acquisition cost
=
Spread
+$0.4301
+195% 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 ⓘ
Fee-for-service · 9,130 Rx Managed care · 18,138 Rx
State Medicaid map
Units reimbursed · per 100k residents
40.81,454
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Metronidazole — the program that covers self-administered drugs. 23 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Metronidazole. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$12.08M
Claims incl. refills
571.7K
Beneficiaries
500.3K
Spend / beneficiary
$24.15
Spend / claim
$21.13
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Metronidazole — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 38%
Female · 62%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00713-0637-37 You're viewing this | 1 TUBE in 1 CARTON (0713-0637-37) / 45 g in 1 TUBE | 2011-04-01 | Active |
📄 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
🧬 Clinical Pharmacology
📦 How Supplied / Storage and Handling
📋 Description
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Metronidazole Gel USP is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Apply and rub in a thin film of Metronidazole Gel twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of Metronidazole Gel. Patients may use cosmetics after application of Metronidazole Gel.
⛔ Contraindications ▾
CONTRAINDICATIONS: Metronidazole Gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: Bioavailability studies on the topical administration of 1 gram of Metronidazole Gel (7.5 mg of metronidazole) to the face of 10 rosacea patients showed a maximum serum concentration of 66 nanograms per milliliter in one patient. This concentration is approximately 100 times less than concentrations afforded by a single 250 mg oral tablet. The serum metronidazole concentrations were below the detectable limits of the assay at the majority of time points in all patients.
Three of the patients had no detectable serum concentrations of metronidazole at any time point. The mean dose of gel applied during clinical studies was 600 mg which represents 4.5 mg of metronidazole per application. Therefore, under normal usage levels, the formulation affords minimal serum concentrations of metronidazole.
The mechanisms by which Metronidazole Gel acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Metronidazole Gel USP, 0.75% is supplied in a 45 g tube NDC 0713-0637-37 Storage conditions: Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0637BFCPLNC3 Rev. 07/2022 VC7647
📋 Description ▾
DESCRIPTION: Metronidazole Gel USP, 0.75% contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer homopolymer NF, edetate disodium,methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1 H -imidazole-1-ethanol and has the following structure: Structural Formula
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.