United States· US:65162-680_5897cff8-507a-42b0-bcf2-4712589704df
Promethazine Hydrochloride and Dextromethorphan Hydrobromide
A medicinal product containing promethazine hydrochloride; dextromethorphan hydrobromide, registered in United States by Amneal Pharmaceuticals 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
- PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
- Manufacturer
- Amneal Pharmaceuticals LLC
- 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
- ndc1165162-680-86
- ndc1165162-680-90
- ndc116516268086118 mL in 1 BOTTLE (65162-680-86)
- ndc116516268090473 mL in 1 BOTTLE (65162-680-90)
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/b3aaccff-979f-4c4f-baaa-b6d9d22db37c GET /v1/drugs/b3aaccff-979f-4c4f-baaa-b6d9d22db37c?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": "6.25; 15",
"substance": "PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"productndc": "65162-680",
"dosage_form": "SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/5mL; mg/5mL",
"application_number": "ANDA090575",
"marketing_category": "ANDA"
}See everything about promethazine hydrochloride; dextromethorphan hydrobromide.
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.