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United States· US:65162-846_e40f4475-c8d3-48a6-913f-cf7c8c7b119b

Valsartan and Hydrochlorothiazide

A medicinal product containing valsartan; hydrochlorothiazide, registered in United States by Amneal Pharmaceuticals LLC.

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…normalisedValsartan and HydrochlorothiazideATC—REGISTER NO.US:65162-846_e40f4475…PACKS LISTED8CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
VALSARTAN; HYDROCHLOROTHIAZIDE
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 · 8

  • ndc11
    6516284603
    30 TABLET, FILM COATED in 1 BOTTLE (65162-846-03)
  • ndc11
    6516284609
    90 TABLET, FILM COATED in 1 BOTTLE (65162-846-09)
  • ndc11
    6516284611
    1000 TABLET, FILM COATED in 1 BOTTLE (65162-846-11)
  • ndc11
    6516284650
    500 TABLET, FILM COATED in 1 BOTTLE (65162-846-50)
  • ndc11
    65162-846-50
  • ndc11
    65162-846-03
  • ndc11
    65162-846-09
  • ndc11
    65162-846-11

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/d5a69630-8b84-42a0-8187-1844f3493f18
GET /v1/drugs/d5a69630-8b84-42a0-8187-1844f3493f18?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": "160; 12.5",
  "substance": "VALSARTAN; HYDROCHLOROTHIAZIDE",
  "productndc": "65162-846",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA204382",
  "marketing_category": "ANDA"
}

See everything about valsartan; hydrochlorothiazide.

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.