🇺🇸
United States · US · US:84441-713_41d6dba5-e412-c8d2-e063-6294a90ae8fa
Loperamide Hydrochloride and Simethicone
Orange BookSPLATC P03AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIMO-GEN LABS LLC
CountryUS (United States)
ATC codeP03AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118444171310100 TABLET in 1 BOTTLE (84441-713-10)
Annotations
Orange Book
A211438
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": "84441-713_41d6dba5-e412-c8d2-e063-6294a90ae8fa",
"productndc": "84441-713",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211438",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG;125MG",
"product_no": "001",
"approval_date": "Jun 17, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIMETHICONE; LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "Loperamide Hydrochloride and Simethicone",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA211438",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide Hydrochloride and Simethicone",
"start_marketing_date": "20251023",
"active_numerator_strength": "125; 2"
}Related drugs
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