Terconazole Vaginal Cream 0.8% 8 mg/g Cream, 20 g — NDC 50090-6299-0 (Billing 50090-6299-00)
This is a package of 20 g of Terconazole Vaginal Cream 0.8% 8 mg/g Cream from A-S Medication Solutions, marketed since Feb 2005 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 50090-6299-0 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 50090 labeler · 6299 product · 0 package
- Package marketed since
- Dec 29, 2022
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 20 g per package
- Barcode (UPC-A, from the NDC)
- 3 5009062990 3
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 015931
- GCN: 48381
- HICL (First Databank): 003033
- AHFS class code: 84:04.08.08
- RxCUI (RxNorm): 313227
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Azole Antifungal class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 ↗- 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Terconazole — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 50090-6299-00 You're viewing this Main listing | 20 g in 1 TUBE, WITH APPLICATOR | 2022-12-29 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Terconazole Vaginal Cream 0.8% 8 mg/g 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/gthis 50090-6299-00 | A-S | 20 g | — | BX | FDA listed | — |
| Terconazole 8 mg/g 68071-1626-02 | NuCare | 20 g | — | BX | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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?
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.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from A-S Medication Solutions labeler code 50090
- Atomoxetine 40 mg Capsule NDC 50090-6289-0
- Memantine Hydrochloride 5 mg Tablet NDC 50090-6291-0
- Hydroxyzine hydrochloride 50 mg Tablet NDC 50090-6293-1
- Benzonatate 200 mg Capsule NDC 50090-6294-0
- AZITHROMYCIN 200 mg/5mL Powder, For Suspension NDC 50090-6296-0
- Doxazosin 4 mg Tablet NDC 50090-6298-0
- venlafaxine hydrochloride 37.5 mg Capsule, Extended Release NDC 50090-6301-0
- Rosuvastatin calcium 5 mg Tablet, Film Coated NDC 50090-6302-0
- Bumetanide 2 mg Tablet NDC 50090-6304-0
- Simvastatin 20 mg Tablet, Film Coated NDC 50090-6306-1
- Simvastatin 20 mg Tablet, Film Coated NDC 50090-6307-0
- Bumetanide .5 mg Tablet NDC 50090-6308-0
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Terconazole vaginal cream 0.8% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.8% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION One full applicatorful (5 g) of terconazole vaginal cream 0.8% (40 mg terconazole) should be administered intravaginally once daily at bedtime for three 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 0.8% is not affected by menstruation.
⛔ Contraindications ▾
CONTRAINDICATIONS Patients known to be hypersensitive to terconazole or to any of the components of the cream.
⚠️ Warnings ▾
WARNINGS None.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS During controlled clinical studies conducted in the United States, patients with vulvovaginal candidiasis were treated with terconazole vaginal cream 0.8% for 3 days. Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole vaginal cream 0.8% were headache (21% vs 16% with placebo) and dysmenorrhea (6% vs 2% with placebo). Genital complaints in general, and burning and itching in particular, occurred less frequently in the terconazole vaginal cream 0.8% 3 day regimen (5% vs.
6%-9% with placebo). Other adverse experiences reported with terconazole vaginal cream 0.8% were abdominal pain (3.4% vs. 1% with placebo) and fever (1% vs.
0.3% with placebo). The therapy-related dropout rate was 2.0% for the terconazole vaginal cream 0.8%. The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching, 0.7% with the terconazole vaginal cream 0.8% group and 0.3% with the placebo group.
🔄 Drug Interactions ▾
Drug Interactions: The therapeutic effect of this product is not affected by oral contraceptive usage.
🧒 Pediatric Use ▾
Pediatric Use: Safety and efficacy in children have not been established.
🧓 Geriatric Use ▾
Geriatric 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. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
🆘 Overdosage ▾
OVERDOSAGE Overdosage of terconazole in humans has not been reported to date. 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Following intravaginal administration of terconazole in humans, 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 normal humans, 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 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 women.
The absorption characteristics of terconazole 0.8% in pregnant or non-pregnant patients with vulvovaginal candidiasis were also similar to those found in normal volunteers. Following oral (30 mg) administration of 14 C-labelled terconazole, the harmonic 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 harmonic 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.
Photosensitivity reactions were observed in some normal volunteers following repeated dermal application of terconazole 2.0% 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 0.8%. Microbiology: Terconazole exhibits fungicidal activity in vitro against Candida albicans .
Antifungal activity also has been demonstrated against other fungi. 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. The exact pharmacologic mode of action of terconazole is uncertain; however, it may exert its antifungal activity by the disruption of normal fungal cell membrane permeability.
No resistance to terconazole has developed during successive passages of C. albicans.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Product: 50090-6299 NDC: 50090-6299-0 20 g in a TUBE, WITH APPLICATOR
📋 Description ▾
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. StructuralFormula
⚠️ Precautions ▾
PRECAUTIONS General: 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 a lack of response to terconazole, appropriate microbiological 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 this product 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 (50x the recommended intravaginal human dose of the 0.8% 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 20-40 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 increase 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 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. 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. 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 vaginal cream 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 ▾
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 ▾
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 ▾
Terconazole Vaginal Cream 0.8% PATIENT INSTRUCTIONS 3- DAY THERAPY 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. 5.
Unscrew the applicator from the tube. 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°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].
See end flap 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 infections.
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 very 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 absorb the medication. Instead, use external pads or napkins until you have finished your medication.… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
terconazole cream Label Image
Medicare Part D spend CMS · PART D · 2026 (Q1)
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 | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| 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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |