Back to search
🇺🇸

United States · US · US:50268-482_2b49645c-34d1-c6ab-e063-6394a90aaee5

Loperamide Hydrochloride

Orange BookUNIISPLATC A07DA03

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

Identification

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

Packs · 1

  • ndc11
    5026848215
    50 BLISTER PACK in 1 BOX (50268-482-15) / 1 CAPSULE in 1 BLISTER PACK (50268-482-11)

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A215579
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": "50268-482_2b49645c-34d1-c6ab-e063-6394a90aaee5",
  "productndc": "50268-482",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215579",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Oct 22, 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": "ANDA215579",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loperamide hydrochloride",
  "start_marketing_date": "20230405",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A07DA03.

Access this data programmatically

Query Loperamide Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.