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United States· US:0527-4094_e505b8df-b401-4967-b4d5-c0717a6a1d08

butalbital, acetaminophen and caffeine

A medicinal product containing butalbital; acetaminophen; caffeine, registered in United States by Lannett Company, 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:0527-4094_e505b8df…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
BUTALBITAL; ACETAMINOPHEN; CAFFEINE
Manufacturer
Lannett Company, 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 · 2

  • ndc11
    0527409437
    100 CAPSULE in 1 BOTTLE, PLASTIC (0527-4094-37)
  • ndc11
    0527-4094-37

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/fb4c8b46-ef73-4158-b123-2c5c1d5fa531
GET /v1/drugs/fb4c8b46-ef73-4158-b123-2c5c1d5fa531?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": "0527-4094",
  "dosage_form": "CAPSULE",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA212083",
  "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.