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United States · US · US:37808-375_0d66a0ee-7c30-45a1-b3ec-fe96235dfb75

Anti-Diarrheal

Orange BookUNIISPLATC A07DA03

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

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
    3780837508
    4 BLISTER PACK in 1 CARTON (37808-375-08) / 6 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A076497
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": {
    "769e7182-fa11-4645-8fca-657253f28d9c": {
      "match": "brand_token",
      "title": "ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR SERVICES INC]",
      "spl_version": "25",
      "published_date": "2026-06-01"
    }
  },
  "productid": "37808-375_0d66a0ee-7c30-45a1-b3ec-fe96235dfb75",
  "productndc": "37808-375",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076497",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jun 10, 2003"
      }
    ],
    "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": "ANDA076497",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loperamide HCl",
  "start_marketing_date": "20050503",
  "active_numerator_strength": "2"
}

Related drugs

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