United States· US:0121-1070_acf1463f-bbbe-42e9-9b06-a306e95a4325
Promethazine DM
A medicinal product containing dextromethorphan hydrobromide; promethazine hydrochloride, 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
- DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
- 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
- September 27, 2026
Packs & prices · 4
- ndc110121107004118 mL in 1 BOTTLE (0121-1070-04)
- ndc110121107016473 mL in 1 BOTTLE (0121-1070-16)
- ndc110121-1070-04
- ndc110121-1070-16
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/b24b7b8a-b840-4266-9d71-f9392a33e901 GET /v1/drugs/b24b7b8a-b840-4266-9d71-f9392a33e901?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": "15; 6.25",
"substance": "DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE",
"productndc": "0121-1070",
"dosage_form": "SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/5mL; mg/5mL",
"application_number": "ANDA040649",
"marketing_category": "ANDA"
}See everything about dextromethorphan hydrobromide; promethazine hydrochloride.
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.