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United States · US · US:36800-583_dc29e904-1358-4d41-8eed-d83136200862

topcare loperamide hydrochloride

Orange BookUNIISPLATC A07DA03

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

Identification

ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeA07DA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3680058326
    120 mL in 1 BOTTLE (36800-583-26)
  • ndc11
    3680058334
    240 mL in 1 BOTTLE (36800-583-34)

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A091292
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": {
    "a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
      "match": "brand_token",
      "title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
      "spl_version": "10",
      "published_date": "2026-06-01"
    }
  },
  "productid": "36800-583_dc29e904-1358-4d41-8eed-d83136200862",
  "productndc": "36800-583",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "091292",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG/7.5ML",
        "product_no": "001",
        "approval_date": "May 20, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "topcare loperamide hydrochloride",
  "active_ingred_unit": "mg/7.5mL",
  "application_number": "ANDA091292",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loperamide HCl",
  "start_marketing_date": "20180912",
  "active_numerator_strength": "1"
}

Related drugs

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