Back to search

United States· US:13107-004_ef408ee9-6806-423f-9998-53d81cc71b94

Hydrocodone Bitartrate and Ibuprofen

A hydrocodone and ibuprofen product containing hydrocodone bitartrate; ibuprofen, registered in United States by Aurolife Pharma, LLC.

ATC N02AJ23US 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…normalisedHydrocodone Bitartrate and IbuprofenATCN02AJ23REGISTER NO.US:13107-004_ef408ee9…PACKS LISTED8CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
HYDROCODONE BITARTRATE; IBUPROFEN
Manufacturer
Aurolife Pharma, LLC
Country
United States (US)
ATC code
N02AJ23
ATC class
Hydrocodone and ibuprofen
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 8

  • ndc11
    1310700401
    100 TABLET, FILM COATED in 1 BOTTLE (13107-004-01)
  • ndc11
    1310700405
    500 TABLET, FILM COATED in 1 BOTTLE (13107-004-05)
  • ndc11
    1310700411
    10 TABLET, FILM COATED in 1 BOTTLE (13107-004-11)
  • ndc11
    1310700499
    1000 TABLET, FILM COATED in 1 BOTTLE (13107-004-99)
  • ndc11
    13107-004-01
  • ndc11
    13107-004-05
  • ndc11
    13107-004-11
  • ndc11
    13107-004-99

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/add3a84d-9fa0-4193-bcf3-a58e65461c86
GET /v1/drugs/add3a84d-9fa0-4193-bcf3-a58e65461c86?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": "7.5; 200",
  "substance": "HYDROCODONE BITARTRATE; IBUPROFEN",
  "productndc": "13107-004",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": "CII",
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA204575",
  "marketing_category": "ANDA"
}

See everything about hydrocodone and ibuprofen.

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.