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United States · US · US:37835-131_358df35b-9290-7e92-e063-6394a90a6b07

Anti-diarrheal

Orange BookUNIISPLATC A07DA03

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

Identification

ManufacturerBI-MART
CountryUS (United States)
ATC codeA07DA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    3783513101
    100 TABLET in 1 BOTTLE (37835-131-01)
  • ndc11
    3783513112
    2 BLISTER PACK in 1 CARTON (37835-131-12) / 6 TABLET in 1 BLISTER PACK
  • ndc11
    3783513124
    4 BLISTER PACK in 1 CARTON (37835-131-24) / 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": "37835-131_358df35b-9290-7e92-e063-6394a90a6b07",
  "productndc": "37835-131",
  "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": "20250501",
  "active_numerator_strength": "2"
}

Related drugs

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