Medicine
Sodium phenylbutyrate 0.94 g/g oral powder
Sodium phenylbutyrate 0.94 g/g oral powder is a generic prescription medicine for oral use, 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 20º to 25ºC (68° to 77°F),, Excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Sodium phenylbutyrate
- Brand
- Sold under the generic name
- Strength
- 0.94 g/g
- Dosage form
- Oral powder
- Route
- Oral
- Packs
- 1 bottle
- Manufacturer
- Par Health
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68° to 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
- A16AX03 Sodium phenylbutyrate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 August 2016
- Identifiers
- RxCUI 984105DailyMed set ID 639f5c7e-9f6d-47fb-a417-2be076176a78NDC 49884-006Application ANDA203918
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 250 g in 1 bottle | 49884-006-04 | Par Health | 31 August 2016 |
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 Sodium phenylbutyrate 0.94 g/g oral powder.
Other strengths and forms of Sodium phenylbutyrate
Clinical summary
Sodium phenylbutyrate is a nitrogen binding agent indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamoyl phosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). MedsAcross supplies Sodium phenylbutyrate 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 Sodium phenylbutyrateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BUPHENYL prescribing information (Horizon Therapeutics) · U.S. National Library of Medicine, DailyMed
- Ammonaps: European public assessment report (EPAR) · European Medicines Agency
- Pheburane: European public assessment report (EPAR) · European Medicines Agency
Need Sodium phenylbutyrate 0.94 g/g oral powder 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.