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United States · US · US:70518-4283_401a05f7-7d16-93f5-e063-6294a90a3daa

LOPERAMIDE HYDROCHLORIDE

Orange BookUNIISPLATC A07DA03

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeA07DA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7051842830
    30 CAPSULE in 1 BLISTER PACK (70518-4283-0)
  • ndc11
    7051842831
    30 CAPSULE in 1 BLISTER PACK (70518-4283-1)
  • ndc11
    7051842832
    15 CAPSULE in 1 BLISTER PACK (70518-4283-2)
  • ndc11
    7051842833
    10 CAPSULE in 1 BLISTER PACK (70518-4283-3)

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": "70518-4283_401a05f7-7d16-93f5-e063-6294a90a3daa",
  "productndc": "70518-4283",
  "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": "20250210",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A07DA03.

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