United States· US:62559-490_540ac802-a419-42f7-8f7f-d770ea165243
Diphenoxylate Hydrochloride and Atropine Sulfate
A medicinal product containing diphenoxylate hydrochloride; atropine sulfate, registered in United States by ANI 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
- DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
- 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 · 4
- ndc116255949001100 TABLET in 1 BOTTLE (62559-490-01)
- ndc1162559490101000 TABLET in 1 BOTTLE (62559-490-10)
- ndc1162559-490-01
- ndc1162559-490-10
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Diphenoxylate hydrochloride; atropine sulfate in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaLOMOTILPFIZER CANADA ULC
- PolandReasecGedeon Richter Plc.
- CzechiaREASECGedeon Richter Plc., Budapešť
Authorised across Europe · EMA
The same active substance is authorised in 5 EEA countries. Names it is sold under:
- Cyprus · Lomotil
- Czechia · Reasec
- Hungary · Reasec
- Poland · Reasec
- Slovakia · Reasec
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/dac99bcd-71a7-4149-989f-631de9f308d0 GET /v1/drugs/dac99bcd-71a7-4149-989f-631de9f308d0?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": "2.5; .025",
"substance": "DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE",
"productndc": "62559-490",
"dosage_form": "TABLET",
"dea_schedule": "CV",
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA086727",
"marketing_category": "ANDA"
}See everything about diphenoxylate hydrochloride; atropine sulfate.
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.