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United States · US · US:68071-2700_17dec409-07e2-7ecc-e063-6294a90ac555
Loperamide Hydrochloride
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11680712700010 CAPSULE in 1 BOTTLE, PLASTIC (68071-2700-0)
- ndc11680712700112 CAPSULE in 1 BOTTLE, PLASTIC (68071-2700-1)
- ndc11680712700220 CAPSULE in 1 BOTTLE, PLASTIC (68071-2700-2)
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": "68071-2700_17dec409-07e2-7ecc-e063-6294a90ac555",
"productndc": "68071-2700",
"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
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