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United States · US · US:0025-0061_69fba82d-8e83-4efb-8c88-5175fda71617

Lomotil

In shortageOrange BookUNIISPLATC A03BA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeA03BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
03J5ZE7KA5
ATROPINE SULFATE
RxCUI 153971
Orange Book
N012462
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Atropine Sulfate Injection
Raw payload (JSON)
{
  "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": {
    "f170584a-1072-4fd7-b1dc-6756703483b9": {
      "match": "brand_token",
      "title": "LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "13",
      "published_date": "2026-02-25"
    }
  },
  "productid": "0025-0061_69fba82d-8e83-4efb-8c88-5175fda71617",
  "productndc": "0025-0061",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "012462",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "0.025MG;2.5MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE",
  "shortage_reason": "Atropine Sulfate Injection",
  "shortage_status": "current",
  "proprietary_name": "Lomotil",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA012462",
  "marketing_category": "NDA",
  "nonproprietary_name": "diphenoxylate hydrochloride and atropine sulfate",
  "start_marketing_date": "19600915",
  "active_numerator_strength": ".025; 2.5"
}

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