anti diarrheal

Orange BookUNIISPLATC A07DA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerH E B

CountryUS (United States)

ATC codeA07DA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3780844934
240 mL in 1 BOTTLE (37808-449-34)

Annotations

UNII (FDA Substance ID)

77TI35393C

LOPERAMIDE HYDROCHLORIDE

RxCUI 82038

Orange Book

A091292

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": "37808-449_80acab10-ff9e-4353-8bf0-a9ea6138e047",
  "productndc": "37808-449",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "091292",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG/7.5ML",
        "product_no": "001",
        "approval_date": "May 20, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "anti diarrheal",
  "active_ingred_unit": "mg/7.5mL",
  "application_number": "ANDA091292",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loperamide HCl",
  "start_marketing_date": "20180622",
  "active_numerator_strength": "1"
}

Related drugs

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