🇺🇸
United States · US · US:53943-263_e44c3937-4a74-46c4-a467-398229e5aece
Anti-Diarrheal/Anti-Gas
Orange BookSPLATC P03AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDiscount Drug Mart, Inc
CountryUS (United States)
ATC codeP03AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1153943263334 BLISTER PACK in 1 CARTON (53943-263-33) / 6 TABLET in 1 BLISTER PACK
Annotations
Orange Book
A214541
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"46f5c653-eec2-4729-8aaa-79f2e188eac3": {
"match": "brand_token",
"title": "ANTI-DIARRHEAL/ANTI-GAS CAPLETS (LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG) TABLET [YYBA CORP]",
"spl_version": "1",
"published_date": "2025-08-21"
}
},
"productid": "53943-263_e44c3937-4a74-46c4-a467-398229e5aece",
"productndc": "53943-263",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214541",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG;125MG",
"product_no": "001",
"approval_date": "May 27, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIMETHICONE; LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "Anti-Diarrheal/Anti-Gas",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA214541",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide Hydrochloride, Simethicone",
"start_marketing_date": "20250226",
"active_numerator_strength": "125; 2"
}Related drugs
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