Uses
ORAVIG is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults. ORAVIG is an azole antifungal indicated for the local treatment of oropharyngeal candidiasis in adults.
Source: US FDA prescribing information
Molecule
Miconazole
Also known as miconazole nitrate
Available on request
- Presentations
- 2
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Miconazole is an azole antifungal indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults. It is available as buccal tablets and vaginal suppositories. MedsAcross supplies Miconazole for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Azole Antifungal
- US FDA first approval
- 8 January 1974
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Buccal, Vaginal
- Dosage forms
- Buccal tablet, Vaginal suppository
- Identifiers
- UNII 7NNO0D7S5MRxCUI 6932CAS 22916-47-8DrugBank DB01110Q410534
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
Miconazole is an antifungal drug.
Source: US FDA prescribing information
Dosing overview
Application of one ORAVIG 50 mg buccal tablet to the gum region once daily for 14 consecutive days. Instruct patients not to crush, chew, or swallow tablets.
Source: US FDA prescribing information
Contraindications
ORAVIG is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to miconazole, milk protein concentrate, or any other component of the product. Known hypersensitivity to miconazole, milk protein concentrate, or any other component of the product.
Source: US FDA prescribing information
Warnings and precautions
Hypersensitivity reactions: Anaphylactic reactions have been reported in patients receiving miconazole. Discontinue ORAVIG immediately at the first sign of hypersensitivity.
Source: US FDA prescribing information
Side effects
The following serious adverse drug reactions are discussed in detail in other sections of labeling: Hypersensitivity reactions Most common adverse reactions (≥2%) are: diarrhea, headache, nausea, dysgeusia, upper abdominal pain, and vomiting.
Source: US FDA prescribing information
Interactions
Warfarin: Miconazole may enhance anticoagulant effect. Monitor prothrombin time, INR, and watch for bleeding. Warfarin Concomitant administration of miconazole and warfarin has resulted in enhancement of anticoagulant effect. Cases of bleeding and bruising following the concomitant use of warfarin and topical, intravaginal, or oral miconazole were reported. Closely monitor prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests if ORAVIG is administered concomitantly with warfarin. Also monitor for evidence of bleeding.
Source: US FDA prescribing information
Storage
ORAVIG should be stored at 20 to 25 o C (68 to 77 o F), excursions between 15 and 30 o C permitted at room temperature. Protect from moisture, and keep out of reach of children.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
2 presentations of Miconazole, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Miconazole 200 mg vaginal suppositoryVaginalGeneric name | — | US FDA | Available on request |
| Oravig 50 mg buccal tabletBuccal | Galt Pharmaceuticals | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 8 January 1974 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions
Conditions linked to Miconazole in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Miconazole available for export from India?
Yes, on request. MedsAcross lists 2 presentations of Miconazole and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Miconazole have?
The catalogue lists 1 brand names for Miconazole, including Oravig.
Is Miconazole approved by the US FDA?
Yes. The US FDA first approved Miconazole on 8 January 1974, according to Drugs@FDA.
Does Miconazole need cold chain shipping?
No listed presentation of Miconazole is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
References
- Oravig prescribing information (Galt Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 8 January 2026
Request Miconazole for export supply
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