Metronidazole 7.5 mg/g Gel
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Nitroimidazole Antimicrobial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Metronidazole is used to treat vaginal infections such as bacterial vaginosis (an infection caused from too much harmful bacteria in the vagina). Metronidazole is in a class of medications called nitroimidazole antimicrobials. It works by stopping the growth of bacteria.
Read the full MedlinePlus article ↗- 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:
Metronidazole may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $0.354 | $24.80 / 70 g |
| Medicaid paysCMS SDUD · 12 mo | $0.3630 | $25.41 / 70 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Metronidazole 7.5 mg/g 00713-0575-71 | Cosette | 1 tube | $0.141 | AB | Availability likely | save 60% |
| Metronidazole 7.5 mg/g 16714-0557-01 | Northstar | 1 tube | $0.141 | AB | Availability likely | save 60% |
| Metronidazole Vaginal Gel, 0.75% 7.5 mg/g 21922-0039-23 | Encube | 1 tube | $0.141 | AB | Availability likely | save 60% |
| metronidazole vaginal 7.5 mg/g 45802-0139-70 | Padagis | 1 tube | $0.141 | AB | Availability likely | save 60% |
| Metronidazole 7.5 mg/g 68462-0184-49 | GLENMARK | 1 tube | $0.141 | AB | Availability likely | save 60% |
| metronidazole vaginal 7.5 mg/g 71656-0067-70 | Saptalis | 1 tube | $0.141 | AB | Availability likely | save 60% |
| Metronidazole 7.5 mg/g 73473-0303-70 | Solaris | 1 tube | $0.141 | AB | Availability likely | save 60% |
| Vandazole 7.5 mg/g 00245-0860-70 | Upsher-smith | 1 tube | $0.323 | BX | Availability likely | save 9% |
| Metronidazole 7.5 mg/gthis 68682-0455-70 | Oceanside | 1 tube | $0.354 | — | Discontinued | — |
| Metronidazole 7.5 mg/g 50090-2126-00 | A-S | 70 g | — | — | FDA listed | — |
| metronidazole vaginal 7.5 mg/g 50090-4809-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Metronidazole 7.5 mg/g 50090-7345-00 | A-S | 1 tube | — | AB | FDA listed | — |
| metronidazole vaginal 7.5 mg/g 70518-2814-00 | REMEDYREPACK | 1 tube | — | AB | FDA listed | — |
| Metronidazole 7.5 mg/g 70518-4495-00 | REMEDYREPACK | 1 tube | — | AB | FDA listed | — |
| metronidazole vaginal 7.5 mg/g 70518-4572-00 | REMEDYREPACK | 1 tube | — | AB | FDA listed | — |
| Metronidazole 7.5 mg/g 50090-7160-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Metronidazole 7.5 mg/g 87687-0001-70 | iNutrition | 1 tube | — | AB | Discontinued | — |
| Vagizole 7.5 mg/g 87687-0002-70 | iNutrition | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68682-0455-70 You're viewing this | 1 TUBE, WITH APPLICATOR in 1 CARTON (68682-455-70) / 70 g in 1 TUBE, WITH APPLICATOR | 2015-04-01 | Discontinued by firm |
🧭 About this NDC listing & data coverage
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 | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| 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) | ✓ Available |
Questions about this listing
What does the discontinued status mean for this NDC?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Metronidazole Vaginal Gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). NOTE For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination.
Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans , and Herpes simplex virus should be ruled out.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The recommended dose is one applicator full of Metronidazole Vaginal Gel (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once-a-day dosing, Metronidazole Vaginal Gel should be administered at bedtime.
⛔ Contraindications ▾
CONTRAINDICATIONS Metronidazole Vaginal Gel is contraindicated in patients with a prior history of hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives.
⚠️ Warnings ▾
WARNINGS Convulsive Seizures and Peripheral Neuropathy Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with oral or intravenous metronidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of metronidazole vaginal gel therapy. Metronidazole vaginal gel should be administered with caution to patients with central nervous system diseases.
Psychotic Reactions Psychotic reactions have been reported in alcoholic patients who were using oral metronidazole and disulfiram concurrently. Metronidazole vaginal gel should not be administered to patients who have taken disulfiram within the last 2 weeks.
🤒 Adverse Reactions ▾
ADVERSE EVENTS Clinical Trials There were no deaths or serious adverse events related to drug therapy in clinical trials involving 800 non-pregnant women who received Metronidazole Vaginal Gel. In a randomized, single-blind clinical trial of 505 non-pregnant women who received Metronidazole Vaginal Gel once or twice a day, 2 patients (one from each regimen) discontinued therapy early due to drug-related adverse events. One patient discontinued drug because of moderate abdominal cramping and loose stools, while the other patient discontinued drug because of mild vaginal burning.
These symptoms resolved after discontinuation of drug. Medical events judged to be related, probably related, or possibly related to administration of Metronidazole Vaginal Gel once or twice a day were reported for 195/505 (39%) patients. The incidence of individual adverse reactions were not significantly different between the two regimens.
Unless percentages are otherwise stipulated, the incidence of individual adverse reactions listed below was less than 1%: Reproductive: Vaginal discharge (12%), Symptomatic Candida cervicitis/vaginitis (10%), Vulva/vaginal irritative symptoms (9%), Pelvic discomfort (3%). Gastrointestinal: Gastrointestinal discomfort (7%), Nausea and/or vomiting (4%), Unusual taste (2%), Diarrhea/loose stools (1%), Decreased appetite (1%), Abdominal bloating/gas; thirsty, dry mouth. Neurologic: Headache (5%), Dizziness (2%), Depression.
Dermatologic: Generalized itching or rash. Other: Unspecified cramping (1%), Fatigue, Darkened urine. In previous clinical trials submitted for approved labeling of Metronidazole Vaginal Gel the following was also reported: Laboratory: Increased/decreased white blood cell counts (1.7%).
Other Metronidazole Formulations Other effects that have been reported in association with the use of topical (dermal) formulations of metronidazole include skin irritation, transient skin erythema, and mild skin dryness and burning. None of these adverse events exceeded an incidence of 2% of patients. Metronidazole Vaginal Gel affords minimal peak serum levels and systemic exposure (AUC) of metronidazole compared to 500 mg oral metronidazole dosing.
Although these lower levels of exposure are less likely to produce the common reactions seen with oral metronidazole, the possibility of these and other reactions cannot be excluded presently. The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of metronidazole: Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic tracings. Central Nervous System: (See WARNINGS .) Headache, dizziness, syncope, ataxia, confusion, convulsive seizures, peripheral neuropathy, vertigo, incoordination, irritability, depression, weakness, insomnia.
Gastrointestinal: Abdominal discomfort, nausea, vomiting, diarrhea, an unpleasant metallic taste, anorexia, epigastric distress, abdominal cramping, constipation, “furry” tongue, glossitis, stomatitis, pancreatitis, and modification of taste of alcoholic beverages. Genitourinary: Overgrowth of Candida in the vagina, dyspareunia, decreased libido, proctitis. Hematopoietic: Reversible neutropenia, reversible thrombocytopenia.
Hypersensitivity Reactions: Urticaria; erythematous rash; flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains. Renal: Dysuria, cystitis, polyuria, incontinence, a sense of pelvic pressure, darkened urine. To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🆘 Overdosage ▾
OVERDOSAGE There is no human experience with overdosage of metronidazole vaginal gel. Vaginally applied metronidazole gel, 0.75% could be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS .)
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Normal Subjects Following a single, intravaginal 5 g dose of metronidazole vaginal gel (equivalent to 37.5 mg of metronidazole) to 12 normal subjects, a mean maximum serum metronidazole concentration of 237 ng/mL was reported (range: 152 to 368 ng/mL). This is approximately 2% of the mean maximum serum metronidazole concentration reported in the same subjects administered a single, oral 500 mg dose of metronidazole (mean C max = 12,785 ng/mL, range: 10,013 to 17,400 ng/mL). These peak concentrations were obtained in 6 to 12 hours after dosing with metronidazole vaginal gel and 1 to 3 hours after dosing with oral metronidazole.
The extent of exposure [area under the curve (AUC)] of metronidazole, when administered as a single intravaginal 5 g dose of metronidazole vaginal gel (equivalent to 37.5 mg of metronidazole), was approximately 4% of the AUC of a single oral 500 mg dose of metronidazole (4977 ng-hr/mL and approximately 125,000 ng-hr/mL, respectively). Dose-adjusted comparisons of AUCs demonstrated that, on a mg to mg comparison basis, the absorption of metronidazole, when administered vaginally, was approximately half that of an equivalent oral dosage.
Patients with Bacterial Vaginosis Following single and multiple 5 g doses of metronidazole vaginal gel to 4 patients with bacterial vaginosis, a mean maximum serum metronidazole concentration of 214 ng/mL on day 1 and 294 ng/mL (range: 228 to 349 ng/mL) on day five were reported. Steady-state metronidazole serum concentrations following oral dosages of 400 to 500 mg BID have been reported to range from 6,000 to 20,000 ng/mL. Microbiology The intracellular targets of action of metronidazole on anaerobes are largely unknown.
The 5-nitro group of metronidazole is reduced by metabolically active anaerobes, and studies have demonstrated that the reduced form of the drug interacts with bacterial DNA. However, it is not clear whether interaction with DNA alone is an important component in the bactericidal action of metronidazole on anaerobic organisms. Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis.
(See INDICATIONS AND USAGE .) Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens, Gardnerella vaginalis, Mobiluncus spp . , and Mycoplasma hominis , has not been defined. Nonetheless, metronidazole is an antimicrobial agent active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis: Bacteroides spp . Gardnerella vaginalis Mobiluncus spp .
Peptostreptococcus spp .
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Metronidazole Vaginal Gel, 0.75% is supplied in a 70 g tube and packaged with 5 vaginal applicators. The NDC number for the 70 g tube is 68682-455-70. Store at controlled room temperature 15° to 30°C (59° to 86°F).
Protect from freezing. Clinical Studies In a randomized, single-blind clinical trial of non-pregnant women with bacterial vaginosis who received Metronidazole Vaginal Gel daily for 5 days, the clinical cure rates for evaluable patients determined at 4 weeks after completion of therapy for the QD and BID regimens were 98/185 (53%) and 109/190 (57%), respectively. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: DPT Laboratories, Inc., San Antonio, TX 78215 USA © 2020 Bausch Health Companies Inc. or its affiliates Rev.
10/2020 9432505 Metronidazole Vaginal Gel, 0.75% DIRECTIONS FOR USE 1. Filling the applicator • Remove cap and puncture metal seal on tube with the pointed tip of cap. (See Figure 1) • Screw end of applicator onto tube.
(See Figure 2) • Gently squeeze the tube from the bottom to fill applicator. Plunger will stop when the applicator is full. (See Figure 3) • Unscrew applicator and replace cap on tube.
2. Inserting the applicator • The applicator may be inserted while lying on your back with your knees bent or in any comfortable position. • Hold filled applicator by barrel, and gently insert into vagina as far as it will comfortably go. (See Figure 4) • Slowly press the plunger until it stops to deposit gel into vagina and then withdraw the applicator.
3. Care of the applicator If physician prescribes twice-a-day dosing: • After use, pull the plunger out of the barrel. (See Figure 5) • Wash both plunger and barrel in warm soapy water and rinse thoroughly. • To reassemble applicator, gently push plunger back into barrel.
IMPORTANT For once-a-day dosing, apply one applicator full at bedtime. For twice-a-day dosing, apply one applicator full each morning and evening for 5 days, or as directed by physician. WARNINGS • If significant irritation develops from the use of this medication, discontinue use and consult your physician. • Do not use during pregnancy except under the supervision of a physician. • Keep this and all medications out of reach of children. • For vaginal use only.
Not for use in the eyes, on the skin or in the mouth. Store at room temperature. Avoid exposure to extreme heat or cold.
See end of carton and bottom of tube for lot number and expiration date. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: DPT Laboratories, Inc. San Antonio, TX 78215 USA © 2020 Bausch Health Companies Inc. or its affiliates Rev.
10/2020 9432505 61eb770c-figure-02 61eb770c-figure-03 61eb770c-figure-04 61eb770c-figure-05 61eb770c-figure-06
📋 Description ▾
DESCRIPTION Metronidazole Vaginal Gel is the intravaginal dosage form of the synthetic antibacterial agent, metronidazole, USP at a concentration of 0.75%. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol.
It has a chemical formula of C 6 H 9 N 3 O 3 , a molecular weight of 171.16, and has the following structure: Metronidazole Vaginal Gel is a gelled, purified water solution, containing metronidazole at a concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 4.0. The gel also contains carbomer 934P, edetate disodium, methylparaben, propylparaben, propylene glycol, and sodium hydroxide.
Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole. 61eb770c-figure-01