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Terconazole Vaginal Cream 0.8% 8 mg/g Cream, 20 g — NDC 00168-0347-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Terconazole Vaginal Cream 0.8% 8 mg/g Cream, 20 g — NDC 0168-0347-20 (Billing 00168-0347-20)

by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC · 20 g in 1 TUBE, WITH APPLICATOR

This is a package of 20 g of Terconazole Vaginal Cream 0.8% 8 mg/g Cream from E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, marketed since Feb 2005 and currently FDA-listed; retail pharmacies pay about $0.9865 per g (NADAC). It is this product's only package size.

NDC 00168-0347-20
🏷️ FDA NDC (as labeled) 0168-0347-20 billing pads the labeler segment with a zero
Rx only Brand 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 →

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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 0168-0347-20 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0168 labeler · 0347 product · 20 package
Package marketed since
Dec 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
20 g per package
Barcode (UPC-A, from the NDC)
3 0168034720 2
Medicaid fills, this package
51,288 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0168-0347-20
Product NDC 0168-0347
11-digit billing NDC 00168034720
NCPDP billing unit GM — per gram (weight)
RxCUI 313227
UNII 0KJ2VE664U
Application # NDA021735
SPL Set ID f59448bd-f730-46d2-a785-c2d6205579ff
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-02-01
Route VAGINAL
Dosage form CREAM
Substance TERCONAZOLE
TE code (Orange Book) BX · RLD · RS

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

GPI-14 55104070003720
GPI class Terconazole
GCN Seq No 015931
GCN 48381
HICL code 003033
Ingredient (HICL) Terconazole
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q4
Therapeutic class — intermediate (HIC2) Vaginal Preparations
HIC3 code Q4F
Therapeutic class — specific (HIC3) Vaginal Antifungals
AHFS code 84:04.08.08
AHFS class Azoles (Skin And Mucous Membrane)
FDB label name TERCONAZOLE 0.8% CREAM
FDB brand name Terconazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 015931
  • GCN: 48381
  • GPI-14 (Medi-Span): 55104070003720
  • HICL (First Databank): 003033
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 313227
Why two NDCs? The FDA registers this code as 0168-0347-20 — 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 → 00168-0347-20. 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 Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Triazole derivatives
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 TERCONAZOLE 0.8% CREAM Ingredient Terconazole
📖 What it is MedlinePlus · NLM

Terconazole is used to treat fungal and yeast infections of the vagina. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats vaginal yeast infections, called vulvovaginal candidiasis, caused by Candida. It only works on that type of infection, so your doctor may confirm the diagnosis with lab t...
  • You insert it into the vagina once a day at bedtime for three nights in a row. The cream comes with an applicator, and the suppository is one insert. The cream is not for the mouth...
  • Headache is the most common. Some people have genital burning or itching, painful periods or belly pain. These are usually the things to mention at your next visit if they bother y...
  • Stop and call your doctor if you get skin irritation, fever, chills or flu-like symptoms with the cream. Get emergency help for signs of a severe allergic reaction or severe skin p...
📖 Read our full Terconazole guide →
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 $0.987 $19.73 / 20 g
Medicaid paysCMS SDUD · 12 mo $1.43 $28.62 / 20 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.387 $0.969
▼ Down 25% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00168-0347-20 You're viewing this Main listing 20 g in 1 TUBE, WITH APPLICATOR 2020-12-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Terconazole Vaginal Cream 0.8% 8 mg/gthis 00168-0347-20 E. 20 g $0.987 BX Availability likely —
Terconazole 8 mg/g 51672-1302-00 Sun 1 tube $0.987 BX Availability likely —
Terconazole 8 mg/g 50090-1196-00 A-S 1 tube — BX FDA listed —
Terconazole Vaginal Cream 0.8% 8 mg/g 50090-6299-00 A-S 20 g — BX FDA listed —
Terconazole 8 mg/g 68071-1626-02 NuCare 20 g — BX FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2005
On the market since
Feb 2005
📍
2026
Currently FDA-listed
21 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

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?
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 REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • 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.

8 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

LabelerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application holderFOUGERA PHARMACEUTICALS INC
FDA applicationNDA021735 (NDA)
Labeler code00168
First marketedFeb 2005
Product typeHuman Prescription Drug
Portfolio33 products on file

More NDCs from E. Fougera & Co. a division of Fougera Pharmaceu... labeler code 00168

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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Patient Medication Information 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

1 INDICATIONS AND USAGE Terconazole Vaginal Cream, is indicated for the treatment of vulvovaginal candidiasis in adult females. Terconazole Vaginal Cream is an azole antifungal indicated for the treatment of vulvovaginal candidiasis in adult females. ( 1 )

⏱️ Dosage and Administration 77 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dose is one applicator full of Terconazole Vaginal Cream (5 grams of cream containing 40 mg terconazole) administered intravaginally once daily at bedtime for three consecutive days. Terconazole Vaginal Cream is not for oral or ophthalmic use. • One full applicator (5 grams) of Terconazole Vaginal Cream administered intravaginally once daily at bedtime for three (3) consecutive days. ( 2 ) • Not for oral or ophthalmic use.

( 2 )

💊 Dosage Forms and Strengths 56 words ▾

3 DOSAGE FORMS AND STRENGTHS Terconazole Vaginal Cream, 0.8% contains 8mg terconazole per gram of cream. Each measured dose applicator delivers 5 grams of cream containing 40 mg of terconazole. Vaginal cream containing terconazole 0.8%: supplied in a 20 gram tube with a measured dose applicator. Each applicator delivers 40 mg of terconazole. ( 3 )

⛔ Contraindications 38 words ▾

4 CONTRAINDICATIONS Terconazole Vaginal Cream, 0.8% is contraindicated in patients with known hypersensitivity to terconazole or to any of the components of the cream. Known hypersensitivity to terconazole or any other component of the cream ( 4 )

⚠️ Warnings and Cautions 86 words ▾

5 WARNINGS AND PRECAUTIONS Risk of Skin Irritation and Flu-Like Symptoms: Discontinue Terconazole Vaginal Cream and do not retreat if skin irritation, fever, chills or flu-like symptoms are reported during use. ( 5 )

5.1Risk of Skin Irritation and Flu-Like Symptoms Discontinue Terconazole Vaginal Cream and do not retreat, if skin irritation, fever, chills or flu-like symptoms are reported during use.

5.2Hypersensitivity There is no information regarding cross-hypersensitivity between terconazole and other azole antifungal agents. Monitor patients with a history of hypersensitivity to azoles.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 2%) were headache, dysmenorrhea, genital burning and itching, and abdominal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fougera at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and estimating their relative rates. During a controlled clinical trial conducted in the United States, patients with vulvovaginal candidiasis were treated with Terconazole Vaginal Cream, 0.8% for 3 days (n=231) or Terazol®3 for 3 days (n=229) [see Clinical Studies (14)].

Table 1 lists the adverse reactions occurring in ≥2% of patients receiving Terconazole Vaginal Cream in the trial. The therapy-related discontinuation rate was 2.0% for Terconazole Vaginal Cream. The adverse reaction most frequently causing discontinuation of Terconazole Vaginal Cream therapy was vulvovaginal itching (0.7%).

Table 1: Adverse Reactions Occurring in ≥2% of Patients Receiving Terconazole Vaginal Cream in a Randomized, Double-Blind Active Controlled Trial Terconazole Vaginal Cream, 0.8% n=231 (%) Terazol ® 3 n=229 (%) Headache 49 (21) 37(16) Dysmenorrhea 14 (6) 5 (2) Genital Burning and Itching 12 (5) 15-21 (6-9) Abdominal Pain 8 (3.4) 2 (1) Other adverse reactions reported in less than 2% of patients receiving Terconazole Vaginal Cream was fever (1%). Photosensitivity reactions were observed in some normal volunteers following repeated dermal application of terconazole 2.0% (not an approved strength) and 0.8% creams under conditions of filtered artificial ultraviolet light.

Photosensitivity reactions were not observed in U.S. and foreign clinical trials in patients who were treated with other terconazole formulations (i.e., terconazole suppositories or vaginal cream, 0.8%).

🔄 Drug Interactions 20 words ▾

7 DRUG INTERACTIONS Oral Contraceptives: There is no known interaction with the concomitant use of this product and oral contraceptives.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on Terconazole Vaginal Cream use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available data from observational studies with terconazole use in pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies with oral terconazole, no adverse development effects were observed at clinically relevant systemic exposures (see Data).

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.

Data Animal Data There was no evidence of malformations when terconazole was administered orally in rats, or rabbits. There was a delay in fetal ossification at an oral dose of 10 mg/kg/day in rats. Higher doses resulted in decreased litter size, decreased number of viable young and reduced fetal weight in rats.

There was also a delay in ossification and an increase incidence of skeletal variants. The dose of 10 mg/kg/day resulted in a mean peak plasma level of terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 30 times the mean peak plasma level (0.006 mcg/mL) seen in normal subjects after intravaginal administration of terconazole vaginal cream 0.8%. This safety assessment does not account for possible exposure of the fetus through direct transfer to terconazole from the irritated vagina by diffusion across amniotic membranes.

8.2Lactation Risk Summary There are no data on the presence of terconazole in human milk, the effect on the breast-fed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Terconazole Vaginal Cream and any potential adverse effects on the breast-fed infant from Terconazole Vaginal Cream or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of Terconazole Vaginal Cream have not been established in female pediatric patients for the treatment of vulvovaginal candidiasis.

8.5Geriatric Use Clinical studies of Terconazole Vaginal Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no available data on Terconazole Vaginal Cream use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available data from observational studies with terconazole use in pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies with oral terconazole, no adverse development effects were observed at clinically relevant systemic exposures (see Data).

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.

Data Animal Data There was no evidence of malformations when terconazole was administered orally in rats, or rabbits. There was a delay in fetal ossification at an oral dose of 10 mg/kg/day in rats. Higher doses resulted in decreased litter size, decreased number of viable young and reduced fetal weight in rats.

There was also a delay in ossification and an increase incidence of skeletal variants. The dose of 10 mg/kg/day resulted in a mean peak plasma level of terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 30 times the mean peak plasma level (0.006 mcg/mL) seen in normal subjects after intravaginal administration of terconazole vaginal cream 0.8%. This safety assessment does not account for possible exposure of the fetus through direct transfer to terconazole from the irritated vagina by diffusion across amniotic membranes.

🧒 Pediatric Use 25 words ▾

8.4Pediatric Use The safety and effectiveness of Terconazole Vaginal Cream have not been established in female pediatric patients for the treatment of vulvovaginal candidiasis.

🧓 Geriatric Use 29 words ▾

8.5Geriatric Use Clinical studies of Terconazole Vaginal Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🆘 Overdosage 13 words ▾

10 OVERDOSAGE Overdosage of terconazole in humans has not been reported to date.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Terconazole is an antifungal agent [see Microbiology ( 12.4 )] .

12.3Pharmacokinetics Following intravaginal administration of Terconazole Vaginal Cream, 0.8% in adult females, absorption ranged from 5-8% in three hysterectomized subjects and 12-16% in two non-hysterectomized subjects with tubal ligations. Following daily intravaginal administration of 0.8% terconazole 40 mg (0.8% cream x 5 g) for seven days to healthy female subjects, plasma concentrations were low and gradually rose to a daily peak (mean of 5.9 ng/mL or 0.006 mcg/mL) at 6.6 hours. Results from similar studies in female patients with vulvovaginal candidiasis indicate that the slow rate of absorption, the lack of accumulation, and the mean peak plasma concentration of terconazole was not different from that observed in healthy females.

The absorption characteristics of terconazole vaginal cream, 0.8% in pregnant or non-pregnant patients with vulvovaginal candidiasis were also similar to those found in healthy subjects. Following oral (30 mg) administration of 14 C-labelled terconazole, the mean half-life of elimination from the blood for the parent terconazole was 6.9 hours (range 4.0-11.3). Terconazole is extensively metabolized; the plasma AUC for terconazole compared to the AUC for total radioactivity was 0.6%.

Total radioactivity was eliminated from the blood with a mean elimination half-life of 52.2 hours (range 44-60). Excretion of radioactivity was both by renal (32-56%) and fecal (47- 52%) routes. In vitro , terconazole is highly protein bound (94.9%) and the degree of binding is independent of drug concentration.

12.4Microbiology Mechanism of Action Terconazole inhibits the enzyme cytochrome P450 14α-demethylase which leads to inhibition of ergosterol synthesis, an essential component of the fungal cell membrane Activity in vitro Terconazole exhibits fungicidal activity in vitro against Candida albicans . Drug Resistance Studies showed no development of resistance to terconazole during successive passages of C. albicans . However, the clinical significance of such an effect is not known.

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action Terconazole is an antifungal agent [see Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling 43 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Terconazole Vaginal Cream 0.8% is supplied in a 20-gram tube with a measured dose applicator. NDC 0168-0347-20 Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description 94 words ▾

11 DESCRIPTION Terconazole Vaginal Cream, 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis -1-[ p [[2-(2,4-Dichlorophenyl)-2-(1 H -1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4- yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. The structural formula of terconazole is as follows: Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47.

It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol. chemical-structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Risk of Skin Irritation and Flu-like Symptoms Advise the patient to discontinue Terconazole Vaginal Cream, 0.8 % and not to retreat if skin irritation, fever, chills or flu-like symptoms are reported during use. Important Administration Instructions Inform patients using Terconazole Vaginal Cream, 0.8% of the following important administration instructions: • Terconazole Vaginal Cream, 0.8% is for intravaginal use only.

Avoid contact with eyes and inside the nose and mouth. • Terconazole Vaginal Cream, 0.8% should be used for three days as directed, even if you feel better quickly. • Do not use this Terconazole Vaginal Cream for any disorder other than the one for which it was prescribed. • Terconazole Vaginal Cream, 0.8% should be used once a day as directed. • If your sexual partner has itching, redness or discomfort in the genital area, tell your partner to consult a physician and that you are being treated for a yeast infection. • Terconazole Vaginal Cream, 0.8% can be used during a menstrual period but external pads should be used until the medication treatment has been completed.

Tampons may absorb the medication and should not be used. You may wish to wear an absorbent panty liner while using Terconazole Vaginal Cream, 0.8%. • Don’t scratch the vaginal area. Scratching can cause more irritation and spread the infection. • Wash hands before and after applying Terconazole Vaginal Cream, 0.8%.

Inform patients who are prone to vaginal yeast infections of the following additional instructions: • Dry the genital area thoroughly after showering, bathing, or swimming. Change out of a wet bathing suit or damp exercise clothes as soon as possible. A dry environment is less likely to encourage the growth of yeast. • Wipe from front to rear (away from the vagina) after a bowel movement. • Don’t douche unless the healthcare provider specifically tells you to do so.

Douching may disturb the balance of normal bacterial flora and the pH of secretions. The brands listed are the registered trademarks of their respective owners and are not trademarks of Fougera Pharmaceuticals Inc. Manufactured by: E.

FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION PATIENT INFORMATION TERCONAZOLE VAGINAL CREAM (ter kon ah zol) Important: For use in the vagina only. Terconazole vaginal cream is not for use in the mouth or eyes. Read the Patient Information that comes with Terconazole vaginal cream before you start using it and each time you get a refill.

There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment. What is Terconazole vaginal cream?

Terconazole vaginal cream is prescription medicine used to treat vaginal yeast infections caused by a fungus called Candida in adult females. It is not known if Terconazole vaginal cream is safe or effective in female children. Do not use Terconazole vaginal cream if you: are allergic to terconazole or any of the other ingredients of the cream.

See the end of this leaflet for a complete list of ingredients in Terconazole vaginal cream. Before using Terconazole vaginal cream, tell your healthcare provider about all of your medical conditions, including if you: • have had an allergic reaction to another antifungal medicine. • are pregnant or plan to become pregnant. It is not known if Terconazole vaginal cream will harm your unborn baby. • are breastfeeding or plan to breastfeed.

It is not known if Terconazole vaginal cream passes into your breast milk. Tell your healthcare provider about all the medicines that you take including prescription and non-prescription medicines, vitamins and herbal supplements. Certain types of medicines can increase the chance of getting vaginal infections.

How should I use Terconazole vaginal cream? • Use Terconazole vaginal cream exactly as your healthcare provider tells you to use it. • Use 1 full applicator of Terconazole vaginal cream in the vagina each night at bedtime for 3 days in a row. • Terconazole vaginal cream is not for use in the mouth or eyes. • Do not stop using Terconazole vaginal cream before your healthcare provider tells you to, even if you feel better very quickly. Your infection may not clear up completely. • See the end of this leaflet for detailed Instructions for Use about how to use Terconazole vaginal cream correctly. • Avoid scratching the affected area.

Scratching may cause more irritation and spread the infection. • If your sexual partner has itching, redness, or discomfort in the genital area, tell your partner to see their healthcare provider and tell their healthcare provider that you are being treated for a yeast infection. • Terconazole vaginal cream can be used during a menstrual period. You should not use tampons because they absorb the medicine. Use external pads until treatment with Terconazole vaginal cream has been completed. • Follow your healthcare provider’s instructions about how to reduce your chances of getting vaginal yeast infections.

What are possible side effects with Terconazole vaginal cream? Terconazole vaginal cream may cause serious side effects, including skin irritation and flu-like symptoms. Stop using Terconazole vaginal cream and do not use Terconazole vaginal cream again if you get any of the following symptoms during treatment: • skin irritation • fever, chills, or flu-like symptoms If you have any of the symptoms listed above, tell your healthcare provider.

Your healthcare provider may tell you to stop using Terconazole vaginal cream and prescribe a different medicine to treat your fungal infection. Common side effects of Terconazole vaginal cream include: • headache • painful menstrual periods • genital itching and burning • stomach pain Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Terconazole vaginal cream.

Ask your healthcare provider or pharmacist for more information. Call your doctor for advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store Terconazole vaginal cream? • Store Terconazole vaginal cream a… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Following intravaginal administration of Terconazole Vaginal Cream, 0.8% in adult females, absorption ranged from 5-8% in three hysterectomized subjects and 12-16% in two non-hysterectomized subjects with tubal ligations. Following daily intravaginal administration of 0.8% terconazole 40 mg (0.8% cream x 5 g) for seven days to healthy female subjects, plasma concentrations were low and gradually rose to a daily peak (mean of 5.9 ng/mL or 0.006 mcg/mL) at 6.6 hours. Results from similar studies in female patients with vulvovaginal candidiasis indicate that the slow rate of absorption, the lack of accumulation, and the mean peak plasma concentration of terconazole was not different from that observed in healthy females.

The absorption characteristics of terconazole vaginal cream, 0.8% in pregnant or non-pregnant patients with vulvovaginal candidiasis were also similar to those found in healthy subjects. Following oral (30 mg) administration of 14 C-labelled terconazole, the mean half-life of elimination from the blood for the parent terconazole was 6.9 hours (range 4.0-11.3). Terconazole is extensively metabolized; the plasma AUC for terconazole compared to the AUC for total radioactivity was 0.6%.

Total radioactivity was eliminated from the blood with a mean elimination half-life of 52.2 hours (range 44-60). Excretion of radioactivity was both by renal (32-56%) and fecal (47- 52%) routes. In vitro , terconazole is highly protein bound (94.9%) and the degree of binding is independent of drug concentration.

🔬 Clinical Studies 210 words ▾

14 CLINICAL STUDIES The efficacy of Terconazole Vaginal Cream, 0.8% in the treatment of vulvovaginal candidiasis in adult women was evaluated in a multicenter, randomized, double-blind, controlled non-inferiority trial comparing Terconazole Vaginal Cream, 0.8% for 3 days (n=231) to another preparation of terconazole vaginal cream 0.8% active comparator for 3 days (n=229). The modified intent-to-treat population (randomized patients who received treatment and had a positive baseline culture for Candida) consisted of 140 Terconazole Vaginal Cream, 0.8% patients and 153 active comparator patients.

Therapeutic cure defined as clinical and mycological cure was assessed at Visit 3 (Day 21-30). Table 2 shows the therapeutic, clinical and mycological cure rates in this trial. The therapeutic cure rate at Visit 3 was 67.1% for the terconazole group and 52.3% for the active comparator group (95% confidence interval about the 14.8% difference in therapeutic cure rate: 3.0% to 26.6%).

Table 2: Efficacy of Terconazole Vaginal Cream 0.8% for the Treatment of Vulvovaginal Candidiasis in a Randomized, Double-Blind Active Controlled Study* Outcome Terconazole Vaginal Cream 0.8% n=140 (%) Active Control n=153 Treatment Difference (%) [95% Confidence Interval] % Cure % Cure Therapeutic Cure 67.1 52.3 14.8 [3.0, 26.6] Clinical Cure 79.3 66.0 13.3 [2.5, 24.0] Mycological Cure 70.7 56.9 13.8 [2.2, 25.4] * Modified intent-to-treat population

🧪 Nonclinical Toxicology 97 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Studies to determine the carcinogenic potential of terconazole have not been performed. Mutagenesis Terconazole was not mutagenic when tested in vitro for induction of microbial point mutations (Ames test), or for inducing cellular transformation, or in vivo for chromosome breaks (micronucleus test) or dominant lethal mutations in mouse germ cells. Impairment of Fertility No impairment of fertility occurred when female rats were administered terconazole orally up to 40 mg/kg/day (about 10 times the recommended intravaginal human dose based on body surface area comparisons) for a three-month period.

📖 Instructions for Use ~2 min read ▾

INSTRUCTIONS FOR USE Instructions for Use TERCONAZOLE VAGINAL CREAM (ter kon ah zol) For vaginal use only. Do not put Terconazole vaginal cream in your eyes or mouth. Be sure to read, understand, and follow the instructions below for how to use Terconazole vaginal cream, correctly.

Important Information • Use Terconazole vaginal cream exactly as your healthcare provider tells you to use it. • Use1 full applicator of terconazole vaginal cream in the vagina each night at bedtime for 3 days in a row. • Do not stop using Terconazole vaginal cream before your healthcare provider tells you to, even if you feel better very quickly. Your infection may not clear up completely. • If you have questions or if your vaginal symptoms do not go away, contact your healthcare provider. How should I store terconazole vaginal cream? • Store Terconazole vaginal cream at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Terconazole vaginal cream and all medicines out of the reach of children. Step 1. Gather your supplies.

(Figure 1) • 1 Terconazole vaginal cream tube • 1 empty reusable applicator, to fill and give the dose of medicine. Step 2. Wash your hands.

Step 3. Prepare the Applicator: • Remove the cap from the Terconazole vaginal cream tube. • Use the pointed tip on the top of the cap to puncture the seal on the tube. (See Figure 2) • Screw the applicator onto the tube. • Squeeze the tube from the bottom and fill the applicator until the plunger stops.

(See Figure 3) • Unscrew the applicator from the tube. Step 4. Insert the Terconazole vaginal cream: • Lie on your back with knees drawn up toward your chest. • Holding the applicator by the ribbed end of the barrel, insert the filled applicator into the vagina as far as it will comfortably go.

(See Figure 4) • Slowly press the plunger of the applicator to release the cream into the vagina. • Remove the applicator from the vagina. Wash the applicator. Step 5.

Wash the Applicator after Use • Wash the applicator after each use. • Pull the plunger out of the barrel. (See Figure 5) • Wash the applicator pieces with lukewarm, soapy water and then dry them very well. • Put the dry applicator pieces back together by gently pushing the plunger into the barrel as far as it will go. Step 6.

Wash your hands well after you finish washing and drying the applicator. Step 7. Repeat Steps 1 through Step 6 until you finish your course of treatment.

Step 8. When you have finished your treatment, throw away (dispose of) the used applicator and tube in your household trash. Manufactured by: E.

FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 The brands listed are the registered trademarks of their respective owners and are not trademarks of Fougera Pharmaceuticals Inc.

This Instructions for Use has been approved by the U.S Food and Drug Administration Revised: 09/2025 figure-1 figure-2 figure-3 figure-4 figure-5

📄 Package Label / Principal Display Panel 21 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0168-0347-20 Rx Only Terconazole Vaginal Cream 0.8% Tube and Applicator NET WT 20 grams Fougera carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
51.3K
Units reimbursed last 4 qtrs
1M
Gross reimbursed last 4 qtrs
$1.5M
Avg / prescription
$29.26
Avg / unit
$1.4311
Latest quarter Q1 2026
11.9KRx
Medicaid pays / g
$1.4311
gross reimbursed
vs
NADAC / g
$0.9865
acquisition cost
=
Spread
+$0.4446
+45% 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 ⓘ
56% FFS 44% MCO
Fee-for-service · 28,903 Rx Managed care · 22,385 Rx
State Medicaid map
Alaska: no data reported AK Maine: 280 units · 20.1 per 100k residents ME Washington: 2,820 units · 36.1 per 100k residents WA Idaho: 280 units · 14.3 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 980 units · 17.1 per 100k residents MN Wisconsin: 5,320 units · 90.0 per 100k residents WI Michigan: 27,720 units · 276 per 100k residents MI New York: 442,740 units · 2,262 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 17,560 units · 550 per 100k residents NV Wyoming: 280 units · 47.9 per 100k residents WY South Dakota: no data reported SD Iowa: 2,600 units · 81.1 per 100k residents IA Illinois: 17,960 units · 143 per 100k residents IL Indiana: 18,560 units · 270 per 100k residents IN Ohio: 43,640 units · 370 per 100k residents OH Pennsylvania: 3,360 units · 25.9 per 100k residents PA New Jersey: 27,953 units · 301 per 100k residents NJ Massachusetts: 29,000 units · 414 per 100k residents MA California: 53,094 units · 136 per 100k residents CA Utah: 240 units · 7.0 per 100k residents UT Colorado: 2,560 units · 43.6 per 100k residents CO Nebraska: 1,760 units · 89.0 per 100k residents NE Missouri: 3,700 units · 59.7 per 100k residents MO Kentucky: 8,965 units · 198 per 100k residents KY West Virginia: 5,800 units · 328 per 100k residents WV Virginia: 21,320 units · 245 per 100k residents VA Maryland: 36,543 units · 591 per 100k residents MD Connecticut: 35,680 units · 986 per 100k residents CT Rhode Island: no data reported RI Arizona: 7,760 units · 104 per 100k residents AZ New Mexico: 1,680 units · 79.5 per 100k residents NM Kansas: 1,040 units · 35.4 per 100k residents KS Arkansas: no data reported AR Tennessee: 10,300 units · 145 per 100k residents TN North Carolina: 19,880 units · 183 per 100k residents NC South Carolina: 17,585 units · 327 per 100k residents SC Delaware: 980 units · 95.1 per 100k residents DE Oklahoma: 1,540 units · 38.0 per 100k residents OK Louisiana: 20,020 units · 438 per 100k residents LA Mississippi: 3,140 units · 107 per 100k residents MS Alabama: 7,060 units · 138 per 100k residents AL Georgia: 41,100 units · 373 per 100k residents GA D.C.: no data reported DC Hawaii: 2,160 units · 151 per 100k residents HI Texas: 43,820 units · 144 per 100k residents TX Florida: 25,660 units · 113 per 100k residents FL
Units reimbursed · per 100k residents
7.02,262
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 2,262 /100k
2 Connecticut 986 /100k
3 Maryland 591 /100k
4 Nevada 550 /100k
5 Louisiana 438 /100k
6 Massachusetts 414 /100k
7 Georgia 373 /100k
8 Ohio 370 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Terconazole (matched by generic name) — the program that covers self-administered drugs. 4 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 Terconazole. 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
$926.9K
Claims incl. refills
30.3K
Beneficiaries
25.6K
Spend / beneficiary
$36.25
Spend / claim
$30.64
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.
← 00168-0346-46 · E. 00168-0357-30 · E. →
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.