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United States· US:71335-1693_30c2b613-bd3c-46d0-b344-cf46d7a9c616

Diphenoxylate Hydrochloride and Atropine Sulfate

A medicinal product containing diphenoxylate hydrochloride; atropine sulfate, registered in United States by Bryant Ranch Prepack.

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…normalisedDiphenoxylate Hydrochloride and Atrop…ATC—REGISTER NO.US:71335-1693_30c2b61…PACKS LISTED14CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
Manufacturer
Bryant Ranch Prepack
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 · 14

  • ndc11
    71335-1693-6
  • ndc11
    71335-1693-3
  • ndc11
    71335-1693-7
  • ndc11
    7133516931
    20 TABLET in 1 BOTTLE (71335-1693-1)
  • ndc11
    7133516932
    30 TABLET in 1 BOTTLE (71335-1693-2)
  • ndc11
    7133516933
    15 TABLET in 1 BOTTLE (71335-1693-3)
  • ndc11
    7133516934
    10 TABLET in 1 BOTTLE (71335-1693-4)
  • ndc11
    7133516935
    40 TABLET in 1 BOTTLE (71335-1693-5)
  • ndc11
    7133516936
    60 TABLET in 1 BOTTLE (71335-1693-6)
  • ndc11
    7133516937
    90 TABLET in 1 BOTTLE (71335-1693-7)
  • ndc11
    71335-1693-5
  • ndc11
    71335-1693-1
  • ndc11
    71335-1693-2
  • ndc11
    71335-1693-4

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.

All diphenoxylate hydrochloride; atropine sulfate products

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/b50d8b32-4c54-4415-986d-1f4ea3900c3b
GET /v1/drugs/b50d8b32-4c54-4415-986d-1f4ea3900c3b?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": "71335-1693",
  "dosage_form": "TABLET",
  "dea_schedule": "CV",
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA213413",
  "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.