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United States · US · US:71335-2487_e99e3001-97ad-4342-93b3-b66d83c15c85

Loperamide Hydrochloride

Orange BookUNIISPLATC A07DA03

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA07DA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7133524870
    50 CAPSULE in 1 BOTTLE (71335-2487-0)
  • ndc11
    7133524871
    15 CAPSULE in 1 BOTTLE (71335-2487-1)
  • ndc11
    7133524872
    30 CAPSULE in 1 BOTTLE (71335-2487-2)
  • ndc11
    7133524873
    20 CAPSULE in 1 BOTTLE (71335-2487-3)
  • ndc11
    7133524874
    12 CAPSULE in 1 BOTTLE (71335-2487-4)
  • ndc11
    7133524875
    60 CAPSULE in 1 BOTTLE (71335-2487-5)
  • ndc11
    7133524876
    24 CAPSULE in 1 BOTTLE (71335-2487-6)
  • ndc11
    7133524877
    14 CAPSULE in 1 BOTTLE (71335-2487-7)
  • ndc11
    7133524878
    9 CAPSULE in 1 BOTTLE (71335-2487-8)
  • ndc11
    7133524879
    5 CAPSULE in 1 BOTTLE (71335-2487-9)

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A216876
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": "71335-2487_e99e3001-97ad-4342-93b3-b66d83c15c85",
  "productndc": "71335-2487",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "216876",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jan 26, 2023"
      }
    ],
    "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": "ANDA216876",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loperamide Hydrochloride",
  "start_marketing_date": "20230126",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A07DA03.

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