United States· US:70518-3915_3ba26cb7-32e1-5652-e063-6394a90a3692

Diphenoxylate Hydrochloride and Atropine Sulfate

A belladonna alkaloids, tertiary amines product containing diphenoxylate hydrochloride and atropine sulfate, registered in United States by REMEDYREPACK INC..

In shortageATC A03BAOrange BookUS label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: diphenoxylate hydrochloride and atropine sulfate
Manufacturer: REMEDYREPACK INC.
Country: United States (US)
ATC code: A03BA
ATC class: Belladonna alkaloids, tertiary amines
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: June 3, 2026

Packs & prices · 1

ndc11
7051839151
30 TABLET in 1 BLISTER PACK (70518-3915-1)

Regulatory notes

UNII (FDA substance ID)

03J5ZE7KA5

ATROPINE SULFATE

RxCUI 153971

Orange Book

A213413

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Atropine Sulfate Injection

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/e2770c8b-1126-4891-955c-fe008edbf6aa
GET /v1/drugs/e2770c8b-1126-4891-955c-fe008edbf6aa?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.

{
  "unii": {
    "unii": "03J5ZE7KA5",
    "rxcui": "153971",
    "inchikey": "JPKKQJKQTPNWTR-WFEZVHBLSA-N;JPKKQJKQTPNWTR-AAWIVWGASA-N",
    "display_name": "ATROPINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "bd08ed90-dd26-4629-83c0-0f75af6ebb95": {
      "match": "brand_token",
      "title": "DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "8",
      "published_date": "2026-05-25"
    }
  },
  "productid": "70518-3915_3ba26cb7-32e1-5652-e063-6394a90a3692",
  "productndc": "70518-3915",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213413",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "0.025MG;2.5MG",
        "product_no": "001",
        "approval_date": "Feb 20, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE",
  "shortage_reason": "Atropine Sulfate Injection",
  "shortage_status": "current",
  "proprietary_name": "Diphenoxylate Hydrochloride and Atropine Sulfate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA213413",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diphenoxylate hydrochloride and atropine sulfate",
  "start_marketing_date": "20231116",
  "active_numerator_strength": ".025; 2.5"
}

API reference MCP server Plans

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