United States· US:0378-0211_20875d8f-5848-4892-a7fb-ab36b0288215
Chlordiazepoxide and Amitriptyline Hydrochloride
A medicinal product containing chlordiazepoxide; amitriptyline hydrochloride, registered in United States by Mylan Pharmaceuticals Inc..
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
- CHLORDIAZEPOXIDE; AMITRIPTYLINE HYDROCHLORIDE
- Manufacturer
- Mylan 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 · 4
- ndc110378021101100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-01)
- ndc110378021105500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-05)
- ndc110378-0211-01
- ndc110378-0211-05
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Chlordiazepoxide; amitriptyline hydrochloride in 2 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandKlotriptylOrion Corporation
- SwitzerlandLimbitrol, HartkapselMEDA Pharmaceuticals Switzerland GmbH
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/3fb235a7-71e3-4060-acc0-286000c3d95b GET /v1/drugs/3fb235a7-71e3-4060-acc0-286000c3d95b?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; 14",
"substance": "CHLORDIAZEPOXIDE; AMITRIPTYLINE HYDROCHLORIDE",
"productndc": "0378-0211",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": "CIV",
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA071297",
"marketing_category": "ANDA"
}See everything about chlordiazepoxide; amitriptyline 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.