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United States · US · US:36800-224_1d9293db-7ead-4316-a8a3-2c5ff664772c

topcare anti diarrheal

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 · 3

  • ndc11
    3680022453
    12 BLISTER PACK in 1 CARTON (36800-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    3680022462
    24 BLISTER PACK in 1 CARTON (36800-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    3680022491
    6 BLISTER PACK in 1 CARTON (36800-224-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A075232
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": "36800-224_1d9293db-7ead-4316-a8a3-2c5ff664772c",
  "productndc": "36800-224",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075232",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jan 6, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "topcare anti diarrheal",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075232",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loperamide Hydrochloride",
  "start_marketing_date": "20030226",
  "active_numerator_strength": "2"
}

Related drugs

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