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United States· US:70954-158_d4edcb5d-dbe9-44c4-a0a9-d3b6aba4c22d

Clorazepate Dipotassium

A medicinal product containing clorazepate dipotassium, registered in United States by ANI 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…normalisedClorazepate DipotassiumATC—REGISTER NO.US:70954-158_d4edcb5d…PACKS LISTED8CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
CLORAZEPATE DIPOTASSIUM
Manufacturer
ANI 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 · 8

  • ndc11
    7095415810
    100 TABLET in 1 BOTTLE (70954-158-10)
  • ndc11
    7095415820
    500 TABLET in 1 BOTTLE (70954-158-20)
  • ndc11
    7095415830
    30 TABLET in 1 BOTTLE (70954-158-30)
  • ndc11
    7095415850
    30 BLISTER PACK in 1 BOX, UNIT-DOSE (70954-158-50) / 1 TABLET in 1 BLISTER PACK (70954-158-40)
  • ndc11
    70954-158-10
  • ndc11
    70954-158-20
  • ndc11
    70954-158-30
  • ndc11
    70954-158-50

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Clorazepate dipotassium in 6 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All clorazepate dipotassium products

Authorised across Europe · EMA

The same active substance is authorised in 11 EEA countries. Names it is sold under:

  • Belgium · Tranxene, Uni-Tranxene
  • Germany · Tranxilium, Tranxilium Tabs
  • Spain · Clorazepato Normon, Tranxilium
  • France · Tranxene
  • Greece · Tranxene
  • Italy · Transene
  • Lithuania · Tranxene
  • Luxembourg · Tranxene, Uni-Tranxene
  • Netherlands · Tranxène, Tranxène Mb
  • Poland · Cloranxen, Tranxene
  • Portugal · Medipax, Tranxene

Source: European Medicines Agency, Article 57 product data.

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/b5846d6d-9e5c-424d-a23c-a92b46c61be8
GET /v1/drugs/b5846d6d-9e5c-424d-a23c-a92b46c61be8?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": "7.5",
  "substance": "CLORAZEPATE DIPOTASSIUM",
  "productndc": "70954-158",
  "dosage_form": "TABLET",
  "dea_schedule": "CIV",
  "strength_unit": "mg/1",
  "application_number": "ANDA213730",
  "marketing_category": "ANDA"
}

See everything about clorazepate dipotassium.

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.