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United States· US:11534-187_7b8cb532-14e4-4cc6-b799-6855a0c10b14

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

A medicinal product containing acetaminophen; caffeine; butalbital, registered in United States by SUNRISE PHARMACEUTICAL, INC.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedBUTALBITAL, ACETAMINOPHEN AND CAFFEINEATC—REGISTER NO.US:11534-187_7b8cb532…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ACETAMINOPHEN; CAFFEINE; BUTALBITAL
Manufacturer
SUNRISE PHARMACEUTICAL, 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 · 4

  • ndc11
    1153418701
    100 CAPSULE in 1 BOTTLE (11534-187-01)
  • ndc11
    1153418704
    500 CAPSULE in 1 BOTTLE (11534-187-04)
  • ndc11
    11534-187-01
  • ndc11
    11534-187-04

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/f533d39f-fcc2-4145-ae53-0a2e81904192
GET /v1/drugs/f533d39f-fcc2-4145-ae53-0a2e81904192?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": "300; 40; 50",
  "substance": "ACETAMINOPHEN; CAFFEINE; BUTALBITAL",
  "productndc": "11534-187",
  "dosage_form": "CAPSULE",
  "dea_schedule": "CIII",
  "strength_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA207118",
  "marketing_category": "ANDA"
}

See everything about acetaminophen; caffeine; butalbital.

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.