Medicine
Rifabutin 150 mg capsule
Rifabutin 150 mg capsule is a generic prescription medicine for oral use, made by 5 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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Rifabutin
- Brand
- Sold under the generic name
- Strength
- 150 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 60 capsules, 50 pouches and 4 more
- Manufacturers
- RemedyrepackANI Pharmaceuticalsi3 PharmaceuticalsMarlex PharmaceuticalsMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J04AB04 Rifabutin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 April 2014
- Identifiers
- RxCUI 198200DailyMed set ID baf8ec98-bd0c-4b87-a7ee-813335431b89, fd6062e2-17c8-48f4-a1fe-69ebe410f583, c2026b67-4755-4236-96b6-a6b5e7399707 +2NDC 70954-041, 72319-010, 59762-1350 +3Application ANDA215041, ANDA212430, NDA050689
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 |
|---|---|---|---|
| 100 capsule in 1 bottle | 70954-041-10 | ANI Pharmaceuticals | 17 December 2021 |
| 100 capsule in 1 bottle | 72319-010-04 | i3 Pharmaceuticals | 16 April 2026 |
| 100 capsule in 1 bottle | 59762-1350-1 | Mylan Pharmaceuticals | 7 April 2014 |
| 60 capsule in 1 bottle, plastic | 70518-4254-0 | Remedyrepack | 13 January 2025 |
| 60 capsule in 1 bottle, plastic | 70518-4594-0 | Remedyrepack | 24 March 2026 |
| 50 pouch in 1 box / 1 capsule in 1 pouch | 70518-4594-1 | Remedyrepack | 5 June 2026 |
| 100 capsule in 1 bottle | 10135-738-01 | Marlex Pharmaceuticals | 1 May 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 23 December 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
Clinical summary
Rifabutin is a rifamycin antimycobacterial indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection. It is available as capsules for oral use. MedsAcross supplies Rifabutin 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 RifabutinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Rifabutin prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Rifabutin 150 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.