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United States · US · US:73581-101_ae2e0cfe-f5ab-d20f-e053-2995a90a5237

WELMATE Anti Diarrheal Loperamide HCl

Orange BookUNIISPLATC A07DA03

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

Identification

ManufacturerYYBA CORP
CountryUS (United States)
ATC codeA07DA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7358110124
    4 BLISTER PACK in 1 CARTON (73581-101-24) / 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": {
    "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": "73581-101_ae2e0cfe-f5ab-d20f-e053-2995a90a5237",
  "productndc": "73581-101",
  "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": "WELMATE Anti Diarrheal Loperamide HCl",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076497",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LOPERAMIDE HYDROCHLORIDE",
  "start_marketing_date": "20200822",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A07DA03.

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