🇺🇸
United States · US · US:0904-6836_82067b3e-6f6d-4cd0-9bf7-bfbe3eab10e6
loperamide hydrochloride
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110904683620120 mL in 1 BOTTLE (0904-6836-20)
Annotations
UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A091292
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": "0904-6836_82067b3e-6f6d-4cd0-9bf7-bfbe3eab10e6",
"productndc": "0904-6836",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "091292",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1MG/7.5ML",
"product_no": "001",
"approval_date": "May 20, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "loperamide hydrochloride",
"active_ingred_unit": "mg/7.5mL",
"application_number": "ANDA091292",
"marketing_category": "ANDA",
"nonproprietary_name": "loperamide HCl",
"start_marketing_date": "20181129",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code A07DA03.
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- 🇺🇸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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