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United States · US · US:69452-405_4bd07c07-575e-1543-e063-6294a90a9b3c
Loperamide Hydrochloride
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116945240555120 mL in 1 BOTTLE (69452-405-55)
- ndc116945240593240 mL in 1 BOTTLE (69452-405-93)
Annotations
UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A220100
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": "69452-405_4bd07c07-575e-1543-e063-6294a90a9b3c",
"productndc": "69452-405",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "220100",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1MG/7.5ML",
"product_no": "001",
"approval_date": "Sep 19, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "Loperamide Hydrochloride",
"active_ingred_unit": "mg/7.5mL",
"application_number": "ANDA220100",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide Hydrochloride oral",
"start_marketing_date": "20260302",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code A07DA03.
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- 🇺🇸anti diarrhealH E B
- 🇺🇸anti diarrhealMajor Pharmaceuticals
- 🇺🇸anti diarrhealKroger Company
- 🇺🇸anti diarrhealCVS Pharmacy
- 🇺🇸anti diarrhealHyVee Inc
- 🇺🇸anti diarrhealPublix Super Markets Inc
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