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Terconazole 4 mg/g Cream — NDC 51672-1304-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Terconazole 4 mg/g Cream — NDC 51672-1304-6 (Billing 51672-1304-06)

by Sun Pharmaceutical Industries, Inc. · 1 TUBE, WITH APPLICATOR in 1 CARTON / 45 g in 1 TUBE, WITH APPLICATOR

This is a package of Terconazole 4 mg/g Cream from Sun Pharmaceutical Industries, Inc., marketed since Jan 2005 and currently FDA-listed; retail pharmacies pay about $0.5523 per g (NADAC). It is this product's only package size.

NDC 51672-1304-06
🏷️ FDA NDC (as labeled) 51672-1304-6 billing pads the package 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 →

NDC database record

One package, one record: these facts belong to NDC 51672-1304-6 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
51672 labeler · 1304 product · 6 package
Package marketed since
Jan 19, 2005
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5167213046 6
Medicaid fills, this package
94,029 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) 51672-1304-6
Product NDC 51672-1304
11-digit billing NDC 51672130406
NCPDP billing unit GM — per gram (weight)
RxCUI 313226
UNII 0KJ2VE664U
Application # ANDA076043
SPL Set ID 2b3923b5-0a97-428c-b8d2-4a3ceb3447a1
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-01-19
Route VAGINAL
Dosage form CREAM
Substance TERCONAZOLE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 55104070003710
GPI class Terconazole
GCN Seq No 007008
GCN 48380
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 0.4% CREAM
FDB brand name Terconazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007008
  • GCN: 48380
  • GPI-14 (Medi-Span): 55104070003710
  • HICL (First Databank): 003033
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 313226
Why two NDCs? The FDA registers this code as 51672-1304-6 — a 5-4-1 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 package segment → 51672-1304-06. 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 0.4% 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 $0.552 $24.85 / 45 g
Medicaid paysCMS SDUD · 12 mo $0.6913 $31.11 / 45 g
Medicare drug plans payPart D · Q2 2026 $0.6402 $28.81 / 45 g
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.695 $0.552
▼ Down 20% 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
51672-1304-06 You're viewing this Main listing 1 TUBE, WITH APPLICATOR in 1 CARTON / 45 g in 1 TUBE, WITH APPLICATOR 2005-01-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Terconazole 4 mg/g 00168-0346-46 E. 45 g $0.552 AB Availability likely —
Terconazole 4 mg/gthis 51672-1304-06 Sun 1 tube $0.552 AB Availability likely —
Terconazole 4 mg/g 50090-0917-00 A-S 1 tube — AB FDA listed —
Terconazole 4 mg/g 50090-6266-00 A-S 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

🏛️
2005
On the market since
Jan 2005
📍
2026
Currently FDA-listed
21 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Terconazole inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA076043 (ANDA)
Labeler code51672
First marketedJan 2005
Product typeHuman Prescription Drug
Portfolio890 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.

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 41 words ▾

INDICATIONS AND USAGE Terconazole vaginal cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream is effective only for vulvovaginitis caused by the genus Candida , the diagnosis should be confirmed by KOH smears and/or cultures.

⏱️ Dosage and Administration 63 words ▾

DOSAGE AND ADMINISTRATION One full applicator (5 grams) of terconazole vaginal cream (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of terconazole vaginal cream is not affected by menstruation.

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS Patients known to be hypersensitive to terconazole or to any of the components of the cream.

⚠️ Warnings 24 words ▾

WARNINGS Anaphylaxis and toxic epidermal necrolysis have been reported during terconazole therapy. Terconazole therapy should be discontinued if anaphylaxis or toxic epidermal necrolysis develops.

🤒 Adverse Reactions 218 words ▾

ADVERSE REACTIONS Adverse Reactions from Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During controlled clinical studies conducted in the United States, 521 patients with vulvovaginal candidiasis were treated with terconazole 0.4% vaginal cream. Based on comparative analyses with placebo, the adverse experiences considered most likely related to terconazole 0.4% vaginal cream were headache (26% vs.

17% with placebo) and body pain (2.1% vs. 0% with placebo). Fever (1.7% vs.

0.5% with placebo) and chills (0.4% vs, 0% with placebo), vulvovaginal burning, itching and irritation have also been reported. The adverse drug experience on terconazole most frequently causing discontinuation was vulvovaginal itching. Post-marketing Experience The following adverse drug reactions have been first identified during post-marketing experience with terconazole:.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General: Asthenia, Influenza-Like Illness consisting of multiple listed reactions including fever and chills, nausea, vomiting, myalgia, arthralgia, malaise Immune: Hypersensitivity, Anaphylaxis, Face Edema Nervous: Dizziness Respiratory: Bronchospasm Skin: Rash, Toxic Epidermal Necrolysis, Urticaria

🔄 Drug Interactions 14 words ▾

Drug Interactions The therapeutic effect of terconazole is not affected by oral contraceptive usage.

🤰 Pregnancy ~1 min read ▾

Pregnancy Teratogenic Effects Pregnancy Category C There was no evidence of teratogenicity when terconazole was administered orally up to 40 mg/kg/day (100× the recommended intravaginal human dose of the 0.4% vaginal cream formulation) in rats, or 20 mg/kg/day in rabbits, or subcutaneously up to 20 mg/kg/day in rats. Dosages at or below 10 mg/kg/day produced no embryotoxicity; however, there was a delay in fetal ossification at 10 mg/kg/day in rats. There was some evidence of embryotoxicity in rabbits and rats at 20 to 40 mg/kg.

In rats, this was reflected as a decrease in litter size and number of viable young and reduced fetal weight. There was also delay in ossification and an increased incidence of skeletal variants. The no-effect 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 44 times the mean peak plasma level (0.004 mcg/mL) seen in normal subjects after intravaginal administration of terconazole 0.4% vaginal cream.

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. Since terconazole is absorbed from the human vagina, it should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient. Terconazole may be used during the second and third trimester if the potential benefit outweighs the possible risks to the fetus.

🧒 Pediatric Use 11 words ▾

Pediatric Use Safety and efficacy in children have not been established.

🧓 Geriatric Use 42 words ▾

Geriatric Use Clinical studies of terconazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 80 words ▾

OVERDOSAGE In the rat, the oral LD 50 values were found to be 1741 and 849 mg/kg for the male and female, respectively. The oral LD 50 values for the male and female dog were ≅1280 and ≥640 mg/kg, respectively. In the event of oral ingestion of suppository or cream, supportive and symptomatic measures should be carried out. If the cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Absorption Following a single intravaginal application of a suppository containing 240 mg 14 C-terconazole to healthy women, approximately 70% (range: 64 to 76%) of terconazole remains in the vaginal area during the suppository retention period (16 hours); approximately 10% (range: 5 to 16%) of the administered radioactivity was absorbed systemically over 7 days. Maximum plasma concentrations of terconazole occur 5 to 10 hours after intravaginal application of the cream or suppository. Systemic exposure to terconazole is approximately proportional to the applied dose, whether as the cream or suppository.

The rate and extent of absorption of terconazole are similar in patients with vulvovaginal candidiasis (pregnant or non-pregnant) and healthy subjects. Distribution Terconazole is highly protein bound (94.9%) in human plasma and the degree of binding is independent of drug concentration over the range of 0.01 to 5 mcg/mL. Metabolism Systemically absorbed terconazole is extensively metabolized (>95%).

Elimination Across various studies in healthy women, after single or multiple intravaginal administration of terconazole as the cream or suppository/ovule, the mean elimination half-life of unchanged terconazole ranged from 6.4 to 8.5 hours. Following a single intravaginal administration of a suppository containing 240 mg 14 C-terconazole to hysterectomized or tubal ligated women, approximately 3 to 10% (mean ± SD: 5.7 ± 3%) of the administered radioactivity was eliminated in the urine and 2 to 6% (mean ± SD: 4.2 ± 1.6%) was eliminated in the feces during the 7-day collection period.

Multiple Dosing There is no significant increase in maximum plasma concentration or overall exposure (AUC) after multiple daily applications of the cream for 7 days or suppositories for 3 days. Photosensitivity reactions were observed in some normal volunteers following repeated dermal application of terconazole 2% and 0.8% creams under conditions of filtered artificial ultraviolet light. Photosensitivity reactions have not been observed in U.S. and foreign clinical trials in patients who were treated with terconazole suppositories or vaginal cream (0.4% and 0.8%).

Microbiology Mechanism of action Terconazole, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the antifungal activity of terconazole.

Mammalian cell demethylation is less sensitive to terconazole inhibition. Activity in vitro Terconazole exhibits antifungal activity in vitro against Candida albicans and other Candida species. The MIC values of terconazole against most Lactobacillus spp. typically found in the human vagina were ≥ 128 mcg/mL; therefore these beneficial bacteria are not affected by drug treatment.

🧬 Mechanism of Action 61 words ▾

Mechanism of action Terconazole, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the antifungal activity of terconazole. Mammalian cell demethylation is less sensitive to terconazole inhibition.

📦 How Supplied / Storage and Handling 31 words ▾

HOW SUPPLIED Terconazole Vaginal Cream 0.4% is available in 45 gram (NDC 51672-1304-6) tubes with a measured-dose applicator. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 13 words ▾

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 104 words ▾

DESCRIPTION Terconazole Vaginal Cream 0.4% is a white to off-white, water washable cream for intravaginal administration containing 0.4% 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, purified water, and stearyl alcohol. The structural formula of terconazole is as follows: TERCONAZOLE C 26 H 31 CI 2 N 5 O 3 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

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General For vulvovaginal use only. Terconazole is not for ophthalmic or oral use. Discontinue use and do not retreat with terconazole if sensitization, irritation, fever, chills or flu-like symptoms are reported during use.

Laboratory Tests If there is lack of response to terconazole, appropriate microbiologic studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens. Drug Interactions The therapeutic effect of terconazole is not affected by oral contraceptive usage. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Studies to determine the carcinogenic potential of terconazole have not been performed.

Mutagenicity 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 for a three month period. Pregnancy Teratogenic Effects Pregnancy Category C There was no evidence of teratogenicity when terconazole was administered orally up to 40 mg/kg/day (100× the recommended intravaginal human dose of the 0.4% vaginal cream formulation) in rats, or 20 mg/kg/day in rabbits, or subcutaneously up to 20 mg/kg/day in rats.

Dosages at or below 10 mg/kg/day produced no embryotoxicity; however, there was a delay in fetal ossification at 10 mg/kg/day in rats. There was some evidence of embryotoxicity in rabbits and rats at 20 to 40 mg/kg. In rats, this was reflected as a decrease in litter size and number of viable young and reduced fetal weight.

There was also delay in ossification and an increased incidence of skeletal variants. The no-effect 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 44 times the mean peak plasma level (0.004 mcg/mL) seen in normal subjects after intravaginal administration of terconazole 0.4% vaginal cream. 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.

Since terconazole is absorbed from the human vagina, it should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient. Terconazole may be used during the second and third trimester if the potential benefit outweighs the possible risks to the fetus. Nursing Mothers It is not known whether this drug is excreted in human milk.

Animal studies have shown that rat offspring exposed via the milk of treated (40 mg/kg/orally) dams showed decreased survival during the first few post-partum days, but overall pup weight and weight gain were comparable to or greater than controls throughout lactation. Because many drugs are excreted in human milk, and because of the potential for adverse reaction in nursing infants from terconazole, 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 efficacy in children have not been established. Geriatric Use Clinical studies of terconazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🍼 Nursing Mothers 101 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Animal studies have shown that rat offspring exposed via the milk of treated (40 mg/kg/orally) dams showed decreased survival during the first few post-partum days, but overall pup weight and weight gain were comparable to or greater than controls throughout lactation. Because many drugs are excreted in human milk, and because of the potential for adverse reaction in nursing infants from terconazole, 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 80 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Studies to determine the carcinogenic potential of terconazole have not been performed. Mutagenicity 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 for a three month period.

📄 Patient Package Insert ~3 min read ▾

Terconazole Vaginal Cream 0.4% PATIENT INSTRUCTIONS FILLING THE APPLICATOR: 1. Remove the cap from the tube. 2.

Use the pointed tip on the top of the cap to puncture the seal on the tube. 3. Screw the applicator onto the tube.

4. Squeeze the tube from the bottom and fill the applicator until the plunger stops. DO NOT release pressure on the tube until you have separated it from the filled applicator.

5. Unscrew the applicator from the tube. After each use, replace the cap and roll up the tube from the bottom.

USING THE APPLICATOR: 1. Lie on your back with your knees drawn up toward your chest. 2.

Holding the applicator by the ribbed end of the barrel, insert the filled applicator into the vagina as far as it will comfortably go. 3. Slowly press the plunger of the applicator to release the cream into the vagina.

4. Remove the applicator from the vagina. 5.

Apply one applicatorful each night for as many days at bedtime, as directed by your doctor. CLEANING THE APPLICATOR: After each use, you should thoroughly clean the applicator by following the procedure below: 1. Pull the plunger out of the barrel.

2. Wash the pieces with lukewarm, soapy water, and dry them thoroughly. 3.

Put the applicator back together by gently pushing the plunger into the barrel as far as it will go. NOTE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. See end flap of carton or crimp of tube for lot number and expiration date.

A WORD ABOUT YEAST INFECTIONS Why do yeast infections occur? Yeast infections are caused by an organism called Candida (KAN di duh). It may be present in small and harmless amounts in the mouth, digestive tract, and vagina.

Sometimes the natural balance of the vagina becomes upset. This may lead to rapid growth of Candida, which results in a yeast infection. Symptoms of a yeast infection include itching, burning, redness, and an abnormal discharge.

Your doctor can make the diagnosis of a yeast infection by evaluating your symptoms and looking at a sample of the discharge under the microscope. How can I prevent yeast infections? Certain factors may increase your chance of developing a yeast infection.

These factors don't actually cause the problem, but they may create a situation that allows the yeast to grow rapidly. Clothing: Tight jeans, nylon underwear, pantyhose, and wet bathing suits can hold in heat and moisture (two conditions in which yeast organisms thrive). Looser pants or skirts, 100% cotton underwear, and stockings may help avoid this problem.

Diet: Cutting down on sweets, milk products, and artificial sweeteners may reduce the risk of yeast infections. Antibiotics: Antibiotics work by eliminating disease-causing organisms. While they are helpful in curing other problems, antibiotics may lead to an overgrowth of Candida in the vagina.

Pregnancy: Hormonal changes in the body during pregnancy encourage the growth of yeast. This is a very common time for an infection to occur. Until the baby is born, it may be hard to completely eliminate yeast infections.

If you believe you are pregnant, tell your doctor. Menstruation: Sometimes monthly changes in hormone levels may lead to yeast infections. Diabetes: In addition to heat and moisture, yeast thrives on sugar.

Because diabetics often have sugar in their urine, their vaginas are rich in this substance. Careful control of diabetes may help prevent yeast infection. Controlling these factors can help eliminate yeast infections and may prevent them from coming back.

Some other helpful tips: 1. For best results, be sure to use the medication as prescribed by your doctor, even if you feel better quickly. 2.

Avoid sexual intercourse, if your doctor advises you to do so. 3. If your partner has any penile itching, redness, or discomfort, he should consult his physician and mention that you are being treated for a yeast infection.

4. You can use the medication even if you are having your menstrual period. However, you should not use tampons because they may a… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 45 words ▾

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton NDC 51672-1304-6 Terconazole Vaginal Cream 0.4% TUBE AND APPLICATOR FOR VAGINAL USE ONLY. Keep this and all medications out of the reach of children. 45 g Rx only TARO 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 ↗

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 – 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
94K
Units reimbursed last 4 qtrs
4.2M
Gross reimbursed last 4 qtrs
$2.93M
Avg / prescription
$31.11
Avg / unit
$0.6913
Latest quarter Q4 2025
22.7KRx
Medicaid pays / g
$0.6913
gross reimbursed
vs
NADAC / g
$0.5523
acquisition cost
=
Spread
+$0.1390
+25% 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 ⓘ
42% FFS 58% MCO
Fee-for-service · 39,067 Rx Managed care · 54,962 Rx
State Medicaid map
Alaska: 765 units · 104 per 100k residents AK Maine: 2,565 units · 184 per 100k residents ME Washington: 34,245 units · 438 per 100k residents WA Idaho: 4,455 units · 227 per 100k residents ID Montana: 1,170 units · 103 per 100k residents MT North Dakota: 2,430 units · 310 per 100k residents ND Minnesota: 8,957 units · 156 per 100k residents MN Wisconsin: 24,679 units · 418 per 100k residents WI Michigan: 83,122 units · 828 per 100k residents MI New York: 1,145,925 units · 5,855 per 100k residents NY Vermont: no data reported VT New Hampshire: 2,745 units · 196 per 100k residents NH Oregon: 7,630 units · 180 per 100k residents OR Nevada: 21,015 units · 658 per 100k residents NV Wyoming: no data reported WY South Dakota: 900 units · 97.9 per 100k residents SD Iowa: 14,985 units · 467 per 100k residents IA Illinois: 82,035 units · 654 per 100k residents IL Indiana: 75,780 units · 1,104 per 100k residents IN Ohio: 222,840 units · 1,891 per 100k residents OH Pennsylvania: 9,945 units · 76.7 per 100k residents PA New Jersey: 98,917 units · 1,065 per 100k residents NJ Massachusetts: 95,401 units · 1,363 per 100k residents MA California: 252,271 units · 647 per 100k residents CA Utah: 4,012 units · 117 per 100k residents UT Colorado: 16,515 units · 281 per 100k residents CO Nebraska: 8,505 units · 430 per 100k residents NE Missouri: 29,880 units · 482 per 100k residents MO Kentucky: 59,445 units · 1,313 per 100k residents KY West Virginia: 25,470 units · 1,439 per 100k residents WV Virginia: 142,920 units · 1,640 per 100k residents VA Maryland: 209,302 units · 3,387 per 100k residents MD Connecticut: 90,810 units · 2,511 per 100k residents CT Rhode Island: 9,225 units · 842 per 100k residents RI Arizona: 44,460 units · 598 per 100k residents AZ New Mexico: 6,307 units · 298 per 100k residents NM Kansas: 5,310 units · 181 per 100k residents KS Arkansas: 5,940 units · 194 per 100k residents AR Tennessee: 24,210 units · 340 per 100k residents TN North Carolina: 77,715 units · 717 per 100k residents NC South Carolina: 51,210 units · 953 per 100k residents SC Delaware: 7,695 units · 746 per 100k residents DE Oklahoma: 13,410 units · 331 per 100k residents OK Louisiana: 59,677 units · 1,305 per 100k residents LA Mississippi: 8,460 units · 288 per 100k residents MS Alabama: 29,122 units · 570 per 100k residents AL Georgia: 171,090 units · 1,551 per 100k residents GA D.C.: 4,005 units · 590 per 100k residents DC Hawaii: 5,400 units · 376 per 100k residents HI Texas: 401,337 units · 1,316 per 100k residents TX Florida: 337,845 units · 1,494 per 100k residents FL
Units reimbursed · per 100k residents
76.75,855
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 5,855 /100k
2 Maryland 3,387 /100k
3 Connecticut 2,511 /100k
4 Ohio 1,891 /100k
5 Virginia 1,640 /100k
6 Georgia 1,551 /100k
7 Florida 1,494 /100k
8 West Virginia 1,439 /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 — 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.
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.