United States· US:54288-137_1d53fada-d36d-4a1a-bb13-fff7d1a177a0
Phenobarbital Sodium
A medicinal product containing phenobarbital sodium, registered in United States by BPI Labs LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- PHENOBARBITAL SODIUM
- Manufacturer
- BPI Labs LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc11542881371010 VIAL in 1 CARTON (54288-137-10) / 1 mL in 1 VIAL (54288-137-01)
- ndc11542881372525 VIAL in 1 CARTON (54288-137-25) / 1 mL in 1 VIAL (54288-137-01)
- ndc1154288-137-10
- ndc1154288-137-25
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Phenobarbital sodium in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomGardenal Sodium 200mg/1ml solution for injection ampoulesConcord Pharmaceuticals Ltd
- FinlandBarbilettaeOrion Corporation Orion Pharma
- CanadaEPIPHEN 30MGVETOQUINOL N A INC
- NorwayFenemalOrifarm Healthcare A/S
- BelgiumAspasmolLaboratoires Sterop
- SwitzerlandAphenylbarbit 100 mg, TablettenStreuli Pharma AG
- FranceGARDENAL 10 mg, compriméATNAHS PHARMA FRANCE
- GermanyLuminalDesitin Arzneimittel Gmbh
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Belgium · Gardenal, Phenobarbital Sodium Sterop
- Bulgaria · Фенобарбитал Софарма
- Czechia · Luminal, Phenaemal
- Germany · Luminal, Luminaletten
- Denmark · Fenemal
- Estonia · Phenaemal
- Spain · Luminal, Luminaletas
- France · Gardenal
- United Kingdom (Northern Ireland) · Phenobarbital Accord, Phenobarbital Activase
- Greece · Gardenal
- Croatia · Phenobarbiton
- Hungary · Sevenal, Sevenaletta
- Ireland · Phenobarbital Clonmel Healthcare
- Italy · Fenobarbitale Sodico S.A.L.F, Gardenale
- Luxembourg · Gardenal
- Netherlands · Fenobarbital Teva
- Norway · Fenemal
- Poland · Luminalum, Luminalum Unia
- Portugal · Bialminal, Fenobarbital Labesfal
- Romania · Fenobarbital Arena, Fenobarbital Zentiva
- Slovakia · Luminal, Phenaemal 0,1
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/f563d287-b451-4197-b937-723a06332e6b GET /v1/drugs/f563d287-b451-4197-b937-723a06332e6b?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": "INTRAMUSCULAR; INTRAVENOUS",
"source": "ndc",
"strength": "130",
"substance": "PHENOBARBITAL SODIUM",
"productndc": "54288-137",
"dosage_form": "INJECTION",
"dea_schedule": "CIV",
"strength_unit": "mg/mL",
"application_number": null,
"marketing_category": "UNAPPROVED DRUG OTHER"
}See everything about phenobarbital sodium.
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.