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United States · US · US:71610-973_45a1e9d4-58d3-98ef-e063-6394a90aac13

Loperamide Hydrochloride

Orange BookUNIISPLATC A07DA03

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeA07DA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7161097353
    60 CAPSULE in 1 BOTTLE (71610-973-53)
  • ndc11
    7161097360
    90 CAPSULE in 1 BOTTLE (71610-973-60)

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A073192
AB
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": {
    "0b1f8d41-51b3-4362-8de7-46bca5caff12": {
      "match": "brand_token",
      "title": "LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "6",
      "published_date": "2026-06-01"
    }
  },
  "productid": "71610-973_45a1e9d4-58d3-98ef-e063-6394a90aac13",
  "productndc": "71610-973",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "073192",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Apr 30, 1992"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "Loperamide Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA073192",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loperamide Hydrochloride",
  "start_marketing_date": "19930501",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A07DA03.

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