Imodium

Orange BookUNIISPLATC A07DA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerKenvue Brands LLC

CountryUS (United States)

ATC codeA07DA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
5058031701
1 BLISTER PACK in 1 CARTON (50580-317-01) / 6 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
5058031703
4 BLISTER PACK in 1 CARTON (50580-317-03) / 6 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
5058031706
2 BLISTER PACK in 1 CARTON (50580-317-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
5058031712
2 BLISTER PACK in 1 CARTON (50580-317-12) / 6 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

77TI35393C

LOPERAMIDE HYDROCHLORIDE

RxCUI 82038

Orange Book

A075232

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": {
    "ecb91e47-2b0c-47c8-9256-4623d8bc825e": {
      "match": "brand_token",
      "title": "IMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE) TABLET [KENVUE BRANDS LLC]",
      "spl_version": "23",
      "published_date": "2026-01-30"
    }
  },
  "productid": "50580-317_3f75a619-8881-0bb3-e063-6394a90a1bcc",
  "productndc": "50580-317",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075232",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jan 6, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "Imodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075232",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loperamide hydrochloride",
  "start_marketing_date": "20150713",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A07DA03.

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