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United States · US · US:0378-2100_84c39323-d4c3-452c-b89d-d104dcac4346

Loperamide Hydrochloride

Orange BookUNIISPLATC A07DA03

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

Identification

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

Packs · 2

  • ndc11
    0378210001
    100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-01)
  • ndc11
    0378210005
    500 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-05)

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A072741
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": "0378-2100_84c39323-d4c3-452c-b89d-d104dcac4346",
  "productndc": "0378-2100",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "072741",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Sep 18, 1991"
      }
    ],
    "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": "ANDA072741",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loperamide hydrochloride",
  "start_marketing_date": "19910918",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A07DA03.

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