🇺🇸
United States · US · US:60468-005_f54d6351-da06-808b-e053-2a95a90ae4cb
Loperamide Hydrochloride
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
Manufacturerallphamed Pharbil Arzneimittel GmbH
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116046800501100 CAPSULE in 1 BOTTLE (60468-005-01)
- ndc116046800505500 CAPSULE in 1 BOTTLE (60468-005-05)
- ndc11604680053030 CAPSULE in 1 BOTTLE (60468-005-30)
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": "60468-005_f54d6351-da06-808b-e053-2a95a90ae4cb",
"productndc": "60468-005",
"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
Other records sharing ATC code A07DA03.
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- 🇺🇸AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDEAmazon.com Services LLC
- 🇺🇸anti diarrhealHyVee Inc
- 🇺🇸anti diarrhealKroger Company
- 🇺🇸anti diarrhealMajor Pharmaceuticals
- 🇺🇸anti diarrhealH E B
- 🇺🇸anti diarrhealCVS Pharmacy
- 🇺🇸anti diarrhealPublix Super Markets Inc
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