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United States · US · US:69452-271_0d83f614-6730-7d3a-e063-6294a90a6b11
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
- ndc116945227120100 CAPSULE in 1 BOTTLE, PLASTIC (69452-271-20)
- ndc116945227130500 CAPSULE in 1 BOTTLE, PLASTIC (69452-271-30)
Annotations
UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A215579
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": "69452-271_0d83f614-6730-7d3a-e063-6294a90a6b11",
"productndc": "69452-271",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "215579",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "001",
"approval_date": "Oct 22, 2021"
}
],
"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": "ANDA215579",
"marketing_category": "ANDA",
"nonproprietary_name": "loperamide hydrochloride",
"start_marketing_date": "20211201",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code A07DA03.
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- 🇺🇸anti diarrhealMajor Pharmaceuticals
- 🇺🇸anti diarrhealH E B
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