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United States· US:42571-302_3747026e-d9b9-7fb3-e063-6394a90a1641

Chlordiazepoxide and Amitriptyline Hydrochloride

A medicinal product containing amitriptyline hydrochloride; chlordiazepoxide, registered in United States by Micro Labs Limited.

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…normalisedChlordiazepoxide and Amitriptyline Hy…ATC—REGISTER NO.US:42571-302_3747026e…PACKS LISTED4CHECKEDAugust 2, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Manufacturer
Micro Labs Limited
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
August 2, 2026

Packs & prices · 4

  • ndc11
    4257130201
    100 TABLET in 1 BOTTLE (42571-302-01)
  • ndc11
    4257130205
    500 TABLET in 1 BOTTLE (42571-302-05)
  • ndc11
    42571-302-01
  • ndc11
    42571-302-05

Regulatory notes

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

Same medicine, other countries

Amitriptyline hydrochloride; chlordiazepoxide in 2 other countries

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

All amitriptyline hydrochloride; chlordiazepoxide products

Authorised across Europe · EMA

The same active substance is authorised in 2 EEA countries. Names it is sold under:

  • Finland · Klotriptyl, Klotriptyl Mite
  • Italy · Limbitryl

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/eeca0398-cbf3-4510-9636-da376e319347
GET /v1/drugs/eeca0398-cbf3-4510-9636-da376e319347?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": "5; 12.5",
  "substance": "AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE",
  "productndc": "42571-302",
  "dosage_form": "TABLET",
  "dea_schedule": "CIV",
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA211925",
  "marketing_category": "ANDA"
}

See everything about amitriptyline hydrochloride; chlordiazepoxide.

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.