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United States· US:68071-3551_2d3fb2d4-6352-3f26-e063-6294a90a0163

Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution

A medicinal product containing dextromethorphan hydrobromide; promethazine hydrochloride, registered in United States by NuCare Pharmaceuticals,Inc..

US 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…normalisedPromethazine Hydrochloride and Dextro…ATC—REGISTER NO.US:68071-3551_2d3fb2d…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Manufacturer
NuCare Pharmaceuticals,Inc.
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 · 2

  • ndc11
    6807135514
    118 mL in 1 BOTTLE (68071-3551-4)
  • ndc11
    68071-3551-4

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/c9775e54-b340-4133-8fca-98a67f78dae2
GET /v1/drugs/c9775e54-b340-4133-8fca-98a67f78dae2?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": "68071-3551",
  "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.