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United States · US · US:41250-224_24d1aebe-d698-4529-9850-0bf50ad90366

anti diarrheal

Orange BookUNIISPLATC A07DA03

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

Identification

ManufacturerMeijer Distribution Inc
CountryUS (United States)
ATC codeA07DA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4125022453
    12 BLISTER PACK in 1 CARTON (41250-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    4125022462
    24 BLISTER PACK in 1 CARTON (41250-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    4125022491
    6 BLISTER PACK in 1 CARTON (41250-224-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A075232
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "77TI35393C",
    "rxcui": "82038",
    "inchikey": "PGYPOBZJRVSMDS-UHFFFAOYSA-N",
    "display_name": "LOPERAMIDE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "dd993f38-a31f-4739-9496-e14186a89053": {
      "match": "brand_token",
      "title": "ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION, INC.]",
      "spl_version": "6",
      "published_date": "2026-05-21"
    }
  },
  "productid": "41250-224_24d1aebe-d698-4529-9850-0bf50ad90366",
  "productndc": "41250-224",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075232",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jan 6, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "anti diarrheal",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075232",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loperamide Hydrochloride",
  "start_marketing_date": "20030305",
  "active_numerator_strength": "2"
}

Related drugs

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