United States· US:70710-2180_47ef97e0-8853-4254-b969-1a489764cec1
Sodium phenylbutyrate
A sodium phenylbutyrate product containing sodium phenylbutyrate, registered in United States by Zydus Pharmaceuticals USA Inc.. The same ATC class is registered in 14 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Sodium phenylbutyrate is registered in 14 of 19 countries.
Countries holding a registration under ATC A16AX03 (sodium phenylbutyrate), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 8 of them publish a price we can compare per daily dose
Sodium phenylbutyrate · ATC A16AX03
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of sodium phenylbutyrate costs, country by country.
Normalised to the WHO defined daily dose (20 g), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Sodium phenylbutyrate · price per daily dose (20 g)
USD · FX 28 Sept 2026
- CZ Czechia$0.46
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- SODIUM PHENYLBUTYRATE
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Country
- United States (US)
- ATC code
- A16AX03
- ATC class
- Sodium phenylbutyrate
- Defined daily dose
- 20 g, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1170710218081 BOTTLE in 1 CARTON (70710-2180-8) / 250 TABLET in 1 BOTTLE
- ndc1170710-2180-8
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sodium phenylbutyrate in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- IrelandAmmonaps 500 mg TabletsImmedica Pharma AB
- CzechiaAMMONAPSImmedica Pharma AB, Stockholm
- FinlandAmmonapsImmedica Pharma AB
- NorwayAmmonapsImmedica Pharma AB
- SwedenAmmonaps 500 mg TablettImmedica Pharma AB
- United KingdomAmmonaps 500mg tabletsImmedica Pharma AB
- BelgiumAmmonaps 500 mgImmedica Pharma
- CanadaPHEBURANEMEDUNIK CANADA
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Ammonaps, Pheburane
- Liechtenstein · Ammonaps
- Norway · Ammonaps, Pheburane
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/bbdf2835-fea7-433c-a52d-a108af657494 GET /v1/drugs/bbdf2835-fea7-433c-a52d-a108af657494?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "500",
"substance": "SODIUM PHENYLBUTYRATE",
"productndc": "70710-2180",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA220418",
"marketing_category": "ANDA"
}See everything about sodium phenylbutyrate.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.