Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy
⚠️
Other active recalls for Miconazole Nitrate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 10, 2024 — Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list. (MEDLINE INDUSTRIES, LP - Northfield)· FDA recall D-0315-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Therapeutic class — broad (HIC1)Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 codeQ4
Therapeutic class — intermediate (HIC2)Vaginal Preparations
HIC3 codeQ4F
Therapeutic class — specific (HIC3)Vaginal Antifungals
AHFS code84:04.08.08
AHFS classAzoles (Skin And Mucous Membrane)
FDB label nameMICONAZOLE 3 200 MG VAG SUPP
FDB brand nameMiconazole 3
Legend statusF — Federal legend — prescription drug or device
TE code (Orange Book)AB · RLD · RS
Why two NDCs?
The FDA registers this code as 0472-1738-03 — 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 → 00472-1738-03. 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 classAzole Antifungal
Drug family (ATC)Antiinfectives and antiseptics for local oral treatment, Imidazole derivatives, Imidazole and 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.
🏭 Manufacturer & labeler
LabelerActavis Pharma, Inc.
Application holderACTAVIS PHARMA INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
Label name MICONAZOLE 3 200 MG VAG SUPPIngredient Miconazole Nitrate
📗 Our plain-language guide HelloPharmacist
For a 7-night vaginal cream, you insert one full applicator into your vagina at bedtime for 7 nights in a row. If you have itching or irritation on the outside, squeeze a small amo...
I bought a miconazole cream for a vaginal yeast infection — how do I use it correctly?
Yes — topical miconazole creams and powders are specifically made for those conditions. For athlete's foot and ringworm, you'd apply it to clean, dry skin twice a day for 4 weeks....
Can I use miconazole cream on my skin for athlete's foot or jock itch?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about Miconazole Nitrate?
Ask a licensed pharmacist directly — free, answered by our team.
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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
Price system
Per ea
Per package
Retail pharmacies payNADAC · weekly
$13.887
$41.66 / 3 suppositories
Medicaid paysCMS SDUD · 12 mo
$15.83
$47.49 / 3 suppositories
Medicare drug plans payPart D · Q2 2026
$14.33
$42.98 / 3 suppositories
NADAC price history (per ea) — tap or hover for the price & month
▲ Up 15% over the last 11 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.
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
🏛️
1995
On the market since
Jan 1995
📍
2026
Currently FDA-listed
31 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00472-1738-03, 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
5.7K
Units reimbursed last 4 qtrs
19.4K
Gross reimbursed last 4 qtrs
$307.1K
Avg / prescription
$53.60
Avg / unit
$15.8289
Latest quarter Q1 2026
1.3KRx
Medicaid pays / ea
$15.8289
gross reimbursed
vs
NADAC / ea
$13.8865
acquisition cost
=
Spread
+$1.9424
+14% vs cost
What Medicaid paid per ea (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 ⓘ
52% FFS48% MCO
Fee-for-service · 2,983 Rx Managed care · 2,747 Rx
State Medicaid map
Units reimbursed · per 100k residents
0.441.5
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1D.C.41.5 /100k
2New York19.8 /100k
3West Virginia13.6 /100k
4Connecticut13.1 /100k
5Ohio12.5 /100k
6Louisiana11.0 /100k
7Illinois11.0 /100k
8Wisconsin10.4 /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 Miconazole 3 (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Miconazole 3. 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
$35.6K
Claims incl. refills
725
Beneficiaries
649
Spend / beneficiary
$54.91
Spend / claim
$49.15
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Miconazole Nitrate — the ingredient across all brands.
Top reported reactions
Vulvovaginal Burning Sensation1,864
Vulvovaginal Pain1,001
Vulvovaginal Pruritus616
Condition Aggravated570
Vaginal Haemorrhage482
Vulvovaginal Discomfort460
Vulvovaginal Swelling317
Age at onset
Neonate8
Infant6
Child15
Adolescent12
Adult526
Elderly274
Reporter sex
Male · 18%
Female · 81%
Unknown · 0%
Serious outcomes
Hospitalization1,647
Life-threatening293
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
Package NDC
Description
Marketing start
Status
00472-1738-03 You're viewing this
3 SUPPOSITORY in 1 CARTON (0472-1738-03)
1995-01-18
Active
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
INDICATIONS AND USAGE Miconazole Nitrate Vaginal Suppositories USP, 200 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). Effectiveness in pregnancy has not been established. As miconazole nitrate is effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smear and/or cultures.
Other pathogens commonly associated with vulvovaginitis ( Trichomonas and Haemophilus vaginalis [Gardnerella] ) should be ruled out by appropriate laboratory methods.
⏱️Dosage and Administration47 words▾
DOSAGE AND ADMINISTRATION Miconazole Nitrate Vaginal Suppositories USP, 200 mg: One suppository (miconazole nitrate, 200 mg) is inserted 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 to rule out other pathogens.
⛔Contraindications9 words▾
CONTRAINDICATIONS Patients known to be hypersensitive to this drug.
🤒Adverse Reactions85 words▾
ADVERSE REACTIONS During clinical studies with Miconazole Nitrate Vaginal Suppositories USP, 200 mg, 301 patients were treated. The incidence of vulvovaginal burning, itching or irritation was 2%. Complaints of cramping (2%) and headaches (1 .
3%) were also reported. Other complaints (hives, skin rash) occurred with less than a 0 . 5% incidence.
The therapy-related dropout rate was 0 . 3%. To report SUSPECTED ADVERSE EVENTS, contact Teva Pharmaceuticals USA, Inc., at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
🤰Pregnancy84 words▾
Pregnancy Since imidazoles are absorbed in small amounts from the human vagina, they should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient. Clinical studies, during which miconazole nitrate vaginal cream and suppositories were used for up to 14 days, were reported to include 541 pregnant patients. Follow-up reports available in 471 of these patients reveal no adverse effects or complications attributable to miconazole nitrate therapy in infants born to these women.
🆘Overdosage44 words▾
OVERDOSAGE Overdosage of miconazole nitrate in humans has not been reported to date. In mice, rats, guinea pigs and dogs, the oral LD 50 values were found to be 578 . 1, greater than 640, 275 . 9 and greater than 160 mg/kg, respectively.
🧬Clinical Pharmacology186 words▾
CLINICAL PHARMACOLOGY Miconazole nitrate exhibits fungicidal activity in vitro against species of the genus Candida. The pharmacologic mode of action is unknown. Following intravaginal administration of miconazole nitrate, small amounts are absorbed.
Administration of a single dose of miconazole nitrate vaginal suppositories (100 mg) to healthy subjects resulted in total recovery from the urine and feces of 0 . 85% (±0 . 43%) of the administered dose.
Animal studies indicate that the drug crossed the placenta and doses above those used in humans result in embryo and fetotoxicity (80 mg/kg, orally), although this has not been reported in human subjects (See PRECAUTIONS ). In multi-center clinical trials in 440 women with vulvovaginal candidiasis, the efficacy of treatment with the Miconazole Nitrate Vaginal Suppositories USP, 200 mg for 3 days was compared with treatment for 7 days with Miconazole Nitrate Vaginal Cream 2%. The clinical cure rates (free of microbiological evidence and clinical signs and symptoms of candidiasis at 8 to 10 days and 30 to 35 days post therapy) were numerically lower, although not statistically different, with the 3-Day Suppository when compared with the 7-Day Cream.
📦How Supplied / Storage and Handling51 words▾
HOW SUPPLIED Miconazole Nitrate Vaginal Suppositories USP, 200 mg are available as elliptically shaped white to off-white suppositories in packages of three with a vaginal applicator NDC 0472-1738-03. Store at controlled room temperature 15° to 30°C (59° to 86°F). Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. A 7/2020
📋Description63 words▾
DESCRIPTION Miconazole Nitrate Vaginal Suppositories USP, 200 mg are white to off-white suppositories, each containing the antifungal agent, miconazole nitrate, USP 1-[2,4-Dichloro-β-[(2,4- dichlorobenzyl)oxy] phenethyl]-imidazole mononitrate, 200 mg, in a hydrogenated vegetable oil base. The molecular formula is C 18 H 14 Cl 4 N 2 O•HNO 3 ; the molecular weight is 479.14 and the structural formula may be represented as follows: 009711be-figure-01
No label section mentions that — try another word, or open the full label on DailyMed below.
Glossary — plain-language definitions of medical terms used in this label:
in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.
Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.
candidiasis: An infection caused by a yeast called Candida, which can affect the mouth, throat, skin, or other areas.
Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.
Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.
Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.
Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.
efficacy: How well a treatment works under the controlled conditions of a clinical study.
incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.
Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.
NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.
Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.
suppository: A solid form inserted into the rectum or vagina, where it melts and is absorbed.
trimester: One of the three roughly three-month stages that a pregnancy is divided into.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.
