🇺🇸
United States · US · US:68788-8393_4e0998b5-f4d3-4f1d-9244-07f3c78308c6
Loperamide Hydrochloride
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168788839324 BLISTER PACK in 1 CARTON (68788-8393-2) / 6 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A206548
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": "68788-8393_4e0998b5-f4d3-4f1d-9244-07f3c78308c6",
"productndc": "68788-8393",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "206548",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG",
"product_no": "001",
"approval_date": "Dec 15, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "Loperamide Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206548",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide Hydrochloride",
"start_marketing_date": "20230301",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code A07DA03.
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- 🇺🇸anti diarrhealH E B
- 🇺🇸anti diarrhealMajor Pharmaceuticals
- 🇺🇸anti diarrhealKroger Company
- 🇺🇸anti diarrhealCVS Pharmacy
- 🇺🇸anti diarrhealHyVee Inc
- 🇺🇸anti diarrhealPublix Super Markets Inc
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