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United States · US · US:71335-2111_f836ea3c-8282-4296-8789-e84029eb37f4

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
    7133521110
    50 CAPSULE in 1 BOTTLE (71335-2111-0)
  • ndc11
    7133521111
    15 CAPSULE in 1 BOTTLE (71335-2111-1)
  • ndc11
    7133521112
    30 CAPSULE in 1 BOTTLE (71335-2111-2)
  • ndc11
    7133521113
    20 CAPSULE in 1 BOTTLE (71335-2111-3)
  • ndc11
    7133521114
    12 CAPSULE in 1 BOTTLE (71335-2111-4)
  • ndc11
    7133521115
    60 CAPSULE in 1 BOTTLE (71335-2111-5)
  • ndc11
    7133521116
    24 CAPSULE in 1 BOTTLE (71335-2111-6)
  • ndc11
    7133521117
    14 CAPSULE in 1 BOTTLE (71335-2111-7)
  • ndc11
    7133521118
    9 CAPSULE in 1 BOTTLE (71335-2111-8)
  • ndc11
    7133521119
    5 CAPSULE in 1 BOTTLE (71335-2111-9)

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A215001
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": "71335-2111_f836ea3c-8282-4296-8789-e84029eb37f4",
  "productndc": "71335-2111",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215001",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Oct 6, 2021"
      }
    ],
    "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": "ANDA215001",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loperamide Hydrochloride",
  "start_marketing_date": "20200925",
  "active_numerator_strength": "2"
}

Related drugs

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