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United States · US · US:68998-248_a9d20c87-e8b0-43dc-9a44-806668617978

Anti-Diarrheal

Orange BookUNIISPLATC A07DA03

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

Identification

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

Packs · 1

  • ndc11
    6899824892
    24 CAPSULE in 1 CARTON (68998-248-92)

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A076497
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": {
    "769e7182-fa11-4645-8fca-657253f28d9c": {
      "match": "brand_token",
      "title": "ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR SERVICES INC]",
      "spl_version": "25",
      "published_date": "2026-06-01"
    }
  },
  "productid": "68998-248_a9d20c87-e8b0-43dc-9a44-806668617978",
  "productndc": "68998-248",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "076497",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jun 10, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "Anti-Diarrheal",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076497",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Marc Glassman",
  "start_marketing_date": "20050503",
  "active_numerator_strength": "2"
}

Related drugs

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