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United States · US · US:69452-531_47a779be-990b-5c3b-e063-6394a90ac456
Loperamide hydrochloride and Simethicone
Orange BookSPLATC P03AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeP03AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169452531124 BLISTER PACK in 1 CARTON (69452-531-12) / 6 TABLET in 1 BLISTER PACK
Annotations
Orange Book
A213484
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": "69452-531_47a779be-990b-5c3b-e063-6394a90ac456",
"productndc": "69452-531",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213484",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG;125MG",
"product_no": "001",
"approval_date": "Sep 10, 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": "ANDA213484",
"marketing_category": "ANDA",
"nonproprietary_name": "loperamide hydrochloride and simethicone",
"start_marketing_date": "20260107",
"active_numerator_strength": "125; 2"
}Related drugs
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