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United States · US · US:51660-069_86ddd92a-920c-40b8-b0bd-29bfb3b38bfc
Loperamide HCl and Simethicone
Orange BookSPLATC P03AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOhm Laboratories Inc.
CountryUS (United States)
ATC codeP03AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1151660069066 TABLET in 1 BLISTER PACK (51660-069-06)
- ndc1151660069122 BLISTER PACK in 1 CARTON (51660-069-12) / 6 TABLET in 1 BLISTER PACK
- ndc1151660069183 BLISTER PACK in 1 CARTON (51660-069-18) / 6 TABLET in 1 BLISTER PACK
- ndc1151660069244 BLISTER PACK in 1 CARTON (51660-069-24) / 6 TABLET in 1 BLISTER PACK
Annotations
Orange Book
A077500
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"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": "51660-069_86ddd92a-920c-40b8-b0bd-29bfb3b38bfc",
"productndc": "51660-069",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077500",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG;125MG",
"product_no": "001",
"approval_date": "Sep 6, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIMETHICONE; LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "Loperamide HCl and Simethicone",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA077500",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide HCl and Simethicone",
"start_marketing_date": "20220113",
"active_numerator_strength": "125; 2"
}Related drugs
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