Back to search

United States· US:0406-0485_d718c5ef-69f7-4342-8ac6-772b45f6a726

ACETAMINOPHEN AND CODEINE PHOSPHATE

A medicinal product containing acetaminophen and codeine phosphate, registered in United States by SpecGx LLC.

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…normalisedACETAMINOPHEN AND CODEINE PHOSPHATEATC—REGISTER NO.US:0406-0485_d718c5ef…PACKS LISTED2CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
acetaminophen and codeine phosphate
Manufacturer
SpecGx LLC
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 2

  • ndc11
    0406048501
    100 TABLET in 1 BOTTLE (0406-0485-01)
  • ndc11
    0406048505
    500 TABLET in 1 BOTTLE (0406-0485-05)

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/bddc02dc-7e04-44d0-bb9a-1e464d7052d1
GET /v1/drugs/bddc02dc-7e04-44d0-bb9a-1e464d7052d1?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",
  "productid": "0406-0485_d718c5ef-69f7-4342-8ac6-772b45f6a726",
  "productndc": "0406-0485",
  "dosage_form": "TABLET",
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; CODEINE PHOSPHATE",
  "proprietary_name": "ACETAMINOPHEN AND CODEINE PHOSPHATE",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA040419",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acetaminophen and codeine phosphate",
  "start_marketing_date": "20010531",
  "active_numerator_strength": "300; 60"
}

See everything about acetaminophen and codeine phosphate.

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.