Anti-Diarrheal

Orange BookUNIISPLATC A07DA03

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

Identification

ManufacturerWal-Mart Stores, Inc.

CountryUS (United States)

ATC codeA07DA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4903548312
2 BLISTER PACK in 1 CARTON (49035-483-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

77TI35393C

LOPERAMIDE HYDROCHLORIDE

RxCUI 82038

Orange Book

N021855

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": "49035-483_f0feada3-d253-2da9-e053-2a95a90a178e",
  "productndc": "49035-483",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "021855",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Aug 4, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Aug 4, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "Anti-Diarrheal",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021855",
  "marketing_category": "NDA",
  "nonproprietary_name": "LOPERAMIDE HYDROCHLORIDE",
  "start_marketing_date": "20190101",
  "active_numerator_strength": "2"
}

Related drugs

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