Back to search

United States· US:81005-123_37ca06ac-1f37-4952-e063-6394a90a2a0e

BUTALBITAL AND ACETAMINOPHEN

A medicinal product containing acetaminophen; butalbital, registered in United States by Aarkish Pharmaceuticals NJ 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 AND ACETAMINOPHENATC—REGISTER NO.US:81005-123_37ca06ac…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ACETAMINOPHEN; BUTALBITAL
Manufacturer
Aarkish Pharmaceuticals NJ 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
    81005-123-01
  • ndc11
    8100512301
    100 TABLET in 1 BOTTLE (81005-123-01)

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/cfa7395a-08ab-4ed6-b564-af92a2f56b10
GET /v1/drugs/cfa7395a-08ab-4ed6-b564-af92a2f56b10?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; 50",
  "substance": "ACETAMINOPHEN; BUTALBITAL",
  "productndc": "81005-123",
  "dosage_form": "TABLET",
  "dea_schedule": "CIII",
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA214955",
  "marketing_category": "ANDA"
}

See everything about acetaminophen; 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.