🇺🇸
United States · US · US:50090-7398_fdda3cf0-8782-474c-95a7-5990383112f3
LOPERAMIDE HYDROCHLORIDE
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11500907398015 CAPSULE in 1 BOTTLE (50090-7398-0)
- ndc11500907398312 CAPSULE in 1 BOTTLE (50090-7398-3)
- ndc11500907398430 CAPSULE in 1 BOTTLE (50090-7398-4)
Annotations
UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A218122
AB
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": "50090-7398_fdda3cf0-8782-474c-95a7-5990383112f3",
"productndc": "50090-7398",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "218122",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "001",
"approval_date": "Sep 5, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "LOPERAMIDE HYDROCHLORIDE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218122",
"marketing_category": "ANDA",
"nonproprietary_name": "LOPERAMIDE HYDROCHLORIDE",
"start_marketing_date": "20230905",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code A07DA03.
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- 🇺🇸anti diarrhealHyVee Inc
- 🇺🇸anti diarrhealKroger Company
- 🇺🇸anti diarrhealMajor Pharmaceuticals
- 🇺🇸anti diarrhealH E B
- 🇺🇸anti diarrhealCVS Pharmacy
- 🇺🇸anti diarrhealPublix Super Markets Inc
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