United States· US:0121-1036_3b3068f2-238d-46b3-b80d-a0ae90142908
Hydrocodone Bitartrate and Homatropine Methylbromide
A medicinal product containing hydrocodone bitartrate; homatropine methylbromide, registered in United States by PAI Holdings, LLC dba PAI Pharma.
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; HOMATROPINE METHYLBROMIDE
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- July 26, 2026
Packs & prices · 2
- ndc1101211036404 TRAY in 1 CASE (0121-1036-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05)
- ndc110121-1036-40
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/a21d4a5e-af00-44cf-be1c-aa1a2145a0d9 GET /v1/drugs/a21d4a5e-af00-44cf-be1c-aa1a2145a0d9?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": "1.5; 5",
"substance": "HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE",
"productndc": "0121-1036",
"dosage_form": "SOLUTION",
"dea_schedule": "CII",
"strength_unit": "mg/5mL; mg/5mL",
"application_number": "NDA005213",
"marketing_category": "NDA AUTHORIZED GENERIC"
}See everything about hydrocodone bitartrate; homatropine methylbromide.
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.