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United States · US · US:0363-0375_5cb15e58-9b8c-4663-9f8e-83894f89aa45
Anti-Diarrheal
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWalgreen Company
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1103630375022 BLISTER PACK in 1 CARTON (0363-0375-02) / 6 TABLET in 1 BLISTER PACK
- ndc1103630375084 BLISTER PACK in 1 CARTON (0363-0375-08) / 6 TABLET in 1 BLISTER PACK
- ndc1103630375451 BLISTER PACK in 1 CARTON (0363-0375-45) / 6 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A076497
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": {
"769e7182-fa11-4645-8fca-657253f28d9c": {
"match": "brand_token",
"title": "ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR SERVICES INC]",
"spl_version": "25",
"published_date": "2026-06-01"
}
},
"productid": "0363-0375_5cb15e58-9b8c-4663-9f8e-83894f89aa45",
"productndc": "0363-0375",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076497",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG",
"product_no": "001",
"approval_date": "Jun 10, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "Anti-Diarrheal",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076497",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide HCl",
"start_marketing_date": "20050503",
"active_numerator_strength": "2"
}Related drugs
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