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United States · US · US:25000-001_2081729a-e6bb-44b8-8295-b7810b77df5e
Loperamide Hydrochloride 2mg
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1125000001834 BLISTER PACK in 1 CARTON (25000-001-83) / 6 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A220153
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": "25000-001_2081729a-e6bb-44b8-8295-b7810b77df5e",
"productndc": "25000-001",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "220153",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG",
"product_no": "001",
"approval_date": "Nov 17, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "Loperamide Hydrochloride 2mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA220153",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide Hydrochloride Tablets USP, 2mg",
"start_marketing_date": "20251119",
"active_numerator_strength": "2"
}Related drugs
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