United States· US:53746-116_e109d65b-643b-4c2e-80ad-30c7b3e9c160
Hydrocodone Bitartrate and Ibuprofen
A hydrocodone and ibuprofen product containing hydrocodone bitartrate; ibuprofen, registered in United States by Amneal Pharmaceuticals of New York LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- HYDROCODONE BITARTRATE; IBUPROFEN
- Manufacturer
- Amneal Pharmaceuticals of New York 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 · 2
- ndc1153746-116-01
- ndc115374611601100 TABLET in 1 BOTTLE (53746-116-01)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same class
Other records under N02AJ23
Hydrocodone and ibuprofen, as other registers publish it.
- United StatesHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLC
- United StatesHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLC
- United StatesHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLC
- United StatesHydrocodone Bitartrate and IbuprofenAurolife Pharma, LLC
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/b31df33e-180d-4b04-ba39-dc7e90cdbdcf GET /v1/drugs/b31df33e-180d-4b04-ba39-dc7e90cdbdcf?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": "2.5; 200",
"substance": "HYDROCODONE BITARTRATE; IBUPROFEN",
"productndc": "53746-116",
"dosage_form": "TABLET",
"dea_schedule": "CII",
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA076642",
"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.