🇺🇸
United States · US · US:42799-605_462e0177-dc7f-6e57-e063-6394a90a471a
Loperamide Hydrochloride
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEdenbridge Pharmaceuticals LLC.
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114279960501100 CAPSULE in 1 BOTTLE (42799-605-01)
- ndc114279960502500 CAPSULE in 1 BOTTLE (42799-605-02)
- ndc11427996050330 CAPSULE in 1 BOTTLE (42799-605-03)
Annotations
UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A215001
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": "42799-605_462e0177-dc7f-6e57-e063-6394a90a471a",
"productndc": "42799-605",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "215001",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "001",
"approval_date": "Oct 6, 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": "ANDA215001",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide Hydrochloride",
"start_marketing_date": "20200925",
"active_numerator_strength": "2"
}Related drugs
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