Medicine
Itraconazole 100 mg capsule
Itraconazole 100 mg capsule is a generic prescription medicine for oral use, made by 9 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), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Itraconazole
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 28 capsules, 100 capsules, 30 capsules and 22 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAscend LaboratoriesIndiaTorrent PharmaceuticalsIndiaNorthStar RxLLCAmerican Health PackagingAmneal PharmaceuticalsAvPAKPatriot PharmaceuticalsRising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J02AC02 Itraconazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 February 2005
- Identifiers
- RxCUI 311204DailyMed set ID 23126370-8d6a-4027-bd8f-860e2776ba3a, 349ffcf4-b2cd-4c93-9411-13c39275b8f3, 6242b7ad-eaa0-a524-b6e0-ec33e63407db +7NDC 62332-204, 67877-454, 10147-1700 +7Application ANDA206741, ANDA208591, NDA020083 +3
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 |
|---|---|---|---|
| 28 capsule in 1 carton | 46708-204-04 | Alembic PharmaceuticalsIndia | 16 December 2016 |
| 100 capsule in 1 carton | 46708-204-10 | Alembic PharmaceuticalsIndia | 16 December 2016 |
| 30 capsule in 1 bottle | 46708-204-30 | Alembic PharmaceuticalsIndia | 16 December 2016 |
| 500 capsule in 1 bottle | 46708-204-71 | Alembic PharmaceuticalsIndia | 16 December 2016 |
| 90 capsule in 1 bottle | 46708-204-90 | Alembic PharmaceuticalsIndia | 16 December 2016 |
| 28 capsule in 1 carton | 62332-204-04 | Alembic PharmaceuticalsIndia | 16 December 2016 |
| 100 capsule in 1 carton | 62332-204-10 | Alembic PharmaceuticalsIndia | 16 December 2016 |
| 30 capsule in 1 bottle | 62332-204-30 | Alembic PharmaceuticalsIndia | 16 December 2016 |
| 500 capsule in 1 bottle | 62332-204-71 | Alembic PharmaceuticalsIndia | 16 December 2016 |
| 90 capsule in 1 bottle | 62332-204-90 | Alembic PharmaceuticalsIndia | 16 December 2016 |
| 500 capsule, coated pellets in 1 bottle | 67877-454-05 | Ascend LaboratoriesIndia | 6 December 2017 |
| 30 capsule, coated pellets in 1 bottle | 67877-454-30 | Ascend LaboratoriesIndia | 6 December 2017 |
| 3 blister pack in 1 carton / 10 capsule, coated pellets in 1 blister pack | 67877-454-84 | Ascend LaboratoriesIndia | 6 December 2017 |
| 90 capsule, coated pellets in 1 bottle | 67877-454-90 | Ascend LaboratoriesIndia | 6 December 2017 |
| 500 capsule in 1 bottle | 13668-463-05 | Torrent PharmaceuticalsIndia | 24 August 2018 |
| 30 capsule in 1 bottle | 13668-463-30 | Torrent PharmaceuticalsIndia | 24 August 2018 |
| 28 capsule in 1 carton | 13668-463-37 | Torrent PharmaceuticalsIndia | 24 August 2018 |
| 90 capsule in 1 bottle | 13668-463-90 | Torrent PharmaceuticalsIndia | 24 August 2018 |
| 30 capsule in 1 bottle | 65162-630-03 | Amneal Pharmaceuticals | 27 September 2016 |
| 30 capsule in 1 bottle | 10147-1700-3 | Patriot Pharmaceuticals | 1 February 2005 |
| 30 capsule in 1 bottle | 16571-245-03 | Rising Pharma Holdings | 3 February 2025 |
| 30 blister pack in 1 box, unit-dose / 1 capsule in 1 blister pack | 60687-299-25 | American Health Packaging | 2 May 2017 |
| 20 blister pack in 1 box, unit-dose / 1 capsule in 1 blister pack | 50268-450-12 | AvPAK | 23 March 2018 |
| 7 blister pack in 1 carton / 4 capsule, coated pellets in 1 blister pack | 16714-743-01 | NorthStar RxLLC | 1 September 2017 |
| 30 capsule, coated pellets in 1 bottle | 16714-743-02 | NorthStar RxLLC | 1 September 2017 |
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 11 September 1992 | 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
Alternatives
Other makers and brands of Itraconazole 100 mg capsule.
Other strengths and forms of Itraconazole
Clinical summary
Itraconazole is an azole antifungal indicated for the treatment of fungal infections in immunocompromised and non-immunocompromised patients. It is available as capsules and oral solution. MedsAcross supplies Itraconazole 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 ItraconazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SPORANOX prescribing information (Janssen Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Itraconazole 100 mg capsule 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.