🇺🇸
United States · US · US:70771-1769_b43ff8ed-7175-4a7a-8e42-5c66324b495c
Loperamide hydrochloride
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117077117691100 CAPSULE in 1 BOTTLE (70771-1769-1)
- ndc11707711769410 BLISTER PACK in 1 CARTON (70771-1769-4) / 10 CAPSULE in 1 BLISTER PACK (70771-1769-2)
- ndc117077117695500 CAPSULE in 1 BOTTLE (70771-1769-5)
Annotations
UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A217471
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": "70771-1769_b43ff8ed-7175-4a7a-8e42-5c66324b495c",
"productndc": "70771-1769",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "217471",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "001",
"approval_date": "Mar 23, 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": "ANDA217471",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide hydrochloride",
"start_marketing_date": "20230625",
"active_numerator_strength": "2"
}Related drugs
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