Medicine
Nitisinone 2 mg capsule
Nitisinone 2 mg capsule is a generic prescription medicine for oral use, made by 4 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 room temperature between 20°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Nitisinone
- Brand
- Sold under the generic name
- Strength
- 2 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 1 bottle and 1 more
- Manufacturers
- Analog PharmaBryant Ranch PrepackEton PharmaceuticalsPar Health
- Origin register
- US FDA, United States
- Storage
- Store at room temperature between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C and 30°C (59°F and 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AX04 Nitisinone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 October 2019
- Identifiers
- RxCUI 351173, 351174, 351175 +1DailyMed set ID 437868f5-1c9e-4b0f-8a03-77df8ac0900d, 645c8387-30d5-4a86-a5d8-2f6b5df6d5f0, dc5e4875-fcd7-408c-88c9-4a715f4384b6NDC 63629-2234, 0254-3020, 70505-202 +1Application ANDA211041, ANDA212390, ANDA216201
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 bottle, plastic in 1 carton / 60 capsule in 1 bottle, plastic | 70505-202-60 | Analog Pharma | 15 June 2022 |
| 1 bottle in 1 carton / 60 capsule in 1 bottle | 71863-119-60 | Eton Pharmaceuticals | 15 January 2024 |
| 1 bottle in 1 carton / 60 capsule in 1 bottle | 0254-3020-02 | Par Health | 4 October 2019 |
| 1 bottle in 1 carton / 60 capsule in 1 bottle | 63629-2234-1 | Bryant Ranch Prepack | 22 March 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.
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 Nitisinone 2 mg capsule.
Other strengths and forms of Nitisinone
Clinical summary
Nitisinone is a 4-hydroxyphenyl-pyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. MedsAcross supplies Nitisinone 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 NitisinoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Orfadin prescribing information (Swedish Orphan Biovitrum AB (Publ)) · U.S. National Library of Medicine, DailyMed
- Orfadin: European public assessment report (EPAR) · European Medicines Agency
- Nityr: European public assessment report (EPAR) · European Medicines Agency
Need Nitisinone 2 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.