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United States · US · US:71335-2571_483682ad-b007-48de-a8b4-86a5f761be06

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
    7133525710
    50 CAPSULE in 1 BOTTLE (71335-2571-0)
  • ndc11
    7133525711
    15 CAPSULE in 1 BOTTLE (71335-2571-1)
  • ndc11
    7133525712
    30 CAPSULE in 1 BOTTLE (71335-2571-2)
  • ndc11
    7133525713
    20 CAPSULE in 1 BOTTLE (71335-2571-3)
  • ndc11
    7133525714
    12 CAPSULE in 1 BOTTLE (71335-2571-4)
  • ndc11
    7133525715
    60 CAPSULE in 1 BOTTLE (71335-2571-5)
  • ndc11
    7133525716
    24 CAPSULE in 1 BOTTLE (71335-2571-6)
  • ndc11
    7133525717
    14 CAPSULE in 1 BOTTLE (71335-2571-7)
  • ndc11
    7133525718
    9 CAPSULE in 1 BOTTLE (71335-2571-8)
  • ndc11
    7133525719
    5 CAPSULE in 1 BOTTLE (71335-2571-9)

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A218122
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": "71335-2571_483682ad-b007-48de-a8b4-86a5f761be06",
  "productndc": "71335-2571",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "218122",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Sep 5, 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": "ANDA218122",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LOPERAMIDE HYDROCHLORIDE",
  "start_marketing_date": "20230905",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A07DA03.

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