Medicine
Terconazole 0.4% vaginal cream
Terconazole 0.4% vaginal cream is a generic prescription medicine for vaginal use, made by 3 labelers, 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
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Terconazole
- Brand
- Sold under the generic name
- Strength
- 0.4%
- Dosage form
- Vaginal cream
- Route
- Vaginal
- Packs
- 1 tube, 45 g and 1 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaA-S Medication SolutionsE. Fougera
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G01AG02 Terconazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 January 2005
- Identifiers
- RxCUI 313226DailyMed set ID 2b3923b5-0a97-428c-b8d2-4a3ceb3447a1, b922feb5-cd85-4f13-9a18-913e58f8da83, 10e84353-93d2-461d-8b79-e9294df047ae +1NDC 51672-1304, 50090-0917, 0168-0346 +1Application ANDA076043, ANDA076712
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 tube, with applicator in 1 carton / 45 g in 1 tube, with applicator | 51672-1304-6 | Sun Pharmaceutical IndustriesIndia | 19 January 2005 |
| 45 g in 1 tube, with applicator | 0168-0346-46 | E. Fougera | 18 February 2005 |
| 1 tube, with applicator in 1 carton / 45 g in 1 tube, with applicator | 50090-0917-0 | A-S Medication Solutions | 28 November 2014 |
| 45 g in 1 tube, with applicator | 50090-6266-0 | A-S Medication Solutions | 12 December 2022 |
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 31 December 1987 | 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 Terconazole
Clinical summary
Terconazole is an azole antifungal indicated for the treatment of vulvovaginal candidiasis in adult females. It is available as vaginal cream and vaginal suppositories. MedsAcross supplies Terconazole 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 TerconazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Terconazole Vaginal Cream 0.8% prescribing information (E. Fougera) · U.S. National Library of Medicine, DailyMed
Need Terconazole 0.4% vaginal cream 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.