🇺🇸
United States · US · US:72888-130_47a17dfd-6255-f6f5-e063-6294a90a5660
Loperamide Hydrochloride
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvagen Pharma Ltd.,
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1172888130001000 CAPSULE in 1 BOTTLE (72888-130-00)
- ndc117288813001100 CAPSULE in 1 BOTTLE (72888-130-01)
- ndc117288813005500 CAPSULE in 1 BOTTLE (72888-130-05)
- ndc11728881303030 CAPSULE in 1 BOTTLE (72888-130-30)
Annotations
UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A216876
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": "72888-130_47a17dfd-6255-f6f5-e063-6294a90a5660",
"productndc": "72888-130",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "216876",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "001",
"approval_date": "Jan 26, 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": "ANDA216876",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide Hydrochloride",
"start_marketing_date": "20230126",
"active_numerator_strength": "2"
}Related drugs
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