Medicine
Oravig 50 mg buccal tablet
Oravig 50 mg buccal tablet is a prescription medicine containing Miconazole for buccal use, marketed by Galt Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
ORAVIG should be stored at 20 to 25 • C (68 to 77 • F), excursions between 15…
Key facts
- Active ingredient (INN)
- Miconazole
- Brand
- Oravig
- Strength
- 50 mg
- Dosage form
- Buccal tablet
- Route
- Buccal
- Packs
- 14 tablets
- Marketing authorisation holder
- Galt Pharmaceuticals
- Manufacturer
- Galt Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- ORAVIG should be stored at 20 to 25 • C (68 to 77 • F), excursions between 15 and 30 • C permitted at room temperature. Protect from moisture, and keep out of reach of children.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 December 2021
- Identifiers
- RxCUI 998548, 998550DailyMed set ID dc2427ff-e566-4b48-b289-9e51c011250aNDC 61825-303Application NDA022404
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 14 tablet in 1 bottle | 61825-303-14 | Galt Pharmaceuticals | 31 December 2021 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| 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 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Miconazole
Clinical summary
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
Read about MiconazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Oravig prescribing information (Galt Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Oravig 50 mg buccal tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.