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United States · US · US:46122-544_a5d954e8-f982-4e56-8f77-6baeddc2124e

good neighbor pharmacy loperamide hydrochloride

Orange BookUNIISPLATC A07DA03

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

Identification

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

Packs · 1

  • ndc11
    4612254426
    120 mL in 1 BOTTLE (46122-544-26)

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A091292
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": {
    "d503b10f-85cd-4bb8-9dec-82d651d525fa": {
      "match": "brand_token",
      "title": "GOOD NEIGHBOR PHARMACY EARWAX REMOVAL (CARBAMIDE PEROXIDE) KIT [AMERISOURCE BERGEN]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "46122-544_a5d954e8-f982-4e56-8f77-6baeddc2124e",
  "productndc": "46122-544",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "091292",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG/7.5ML",
        "product_no": "001",
        "approval_date": "May 20, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "good neighbor pharmacy loperamide hydrochloride",
  "active_ingred_unit": "mg/7.5mL",
  "application_number": "ANDA091292",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loperamide HCl",
  "start_marketing_date": "20180813",
  "active_numerator_strength": "1"
}

Related drugs

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