WELMATE Anti Diarrheal Loperamide HCl Softgels

Orange BookUNIISPLATC A07DA03

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

Identification

ManufacturerYYBA CORP

CountryUS (United States)

ATC codeA07DA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7358110224
2 BLISTER PACK in 1 CARTON (73581-102-24) / 12 CAPSULE 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": {
    "cff71b75-fc4e-29ac-e053-2995a90abd50": {
      "match": "brand_token",
      "title": "WELMATE LIDOCAINE PAIN RELIEVING PATCH (LIDOCAINE) PATCH [YYBA CORP]",
      "spl_version": "6",
      "published_date": "2026-03-10"
    }
  },
  "productid": "73581-102_ec6b87f1-e600-21c2-e053-2a95a90ab76d",
  "productndc": "73581-102",
  "dosage_form": "CAPSULE",
  "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": "WELMATE Anti Diarrheal Loperamide HCl Softgels",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021855",
  "marketing_category": "NDA",
  "nonproprietary_name": "LOPERAMIDE HYDROCHLORIDE",
  "start_marketing_date": "20200822",
  "active_numerator_strength": "2"
}

Related drugs

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