United States· US:85534-0046_56cb6d59-e749-3f7c-e063-6394a90a92e7
Butalbital, Acetaminophen, Caffeine
A medicinal product containing butalbital; acetaminophen; caffeine, registered in United States by HAWAII REPACK, INC..
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
- BUTALBITAL; ACETAMINOPHEN; CAFFEINE
- Manufacturer
- HAWAII REPACK, INC.
- 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 · 9
- ndc1185534-0046-0
- ndc1185534-0046-1
- ndc1185534-0046-2
- ndc1185534-0046-3
- ndc1185534-0046-4
- ndc1185534-0046-5
- ndc1185534-0046-6
- ndc1185534-0046-7
- ndc1185534-0046-8
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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/c7d9fa75-7eee-4f7c-848b-ad061f3b217c GET /v1/drugs/c7d9fa75-7eee-4f7c-848b-ad061f3b217c?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": "50; 325; 40",
"substance": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"productndc": "85534-0046",
"dosage_form": "TABLET",
"dea_schedule": "CIII",
"strength_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA209587",
"marketing_category": "ANDA"
}See everything about butalbital; acetaminophen; caffeine.
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.