🇺🇸
United States · US · US:70000-0418_9172bc2f-a9c3-4b2d-9f88-ea9f94491063
leader anti diarrheal
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117000004181120 mL in 1 BOTTLE (70000-0418-1)
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": {
"12971fb2-2314-4443-bf70-b7eb5859b148": {
"match": "brand_token",
"title": "LEADER MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]",
"spl_version": "3",
"published_date": "2026-06-01"
}
},
"productid": "70000-0418_9172bc2f-a9c3-4b2d-9f88-ea9f94491063",
"productndc": "70000-0418",
"dosage_form": "SUSPENSION",
"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": "leader anti diarrheal",
"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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