🇺🇸
United States · US · US:73581-178_3cb7329c-a47c-5d2f-e063-6394a90a053d
Anti-Diarrheal/Anti-Gas Caplets
Orange BookSPLATC P03AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerYYBA CORP
CountryUS (United States)
ATC codeP03AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1173581178244 BLISTER PACK in 1 CARTON (73581-178-24) / 6 TABLET in 1 BLISTER PACK
Annotations
Orange Book
A213484
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": "73581-178_3cb7329c-a47c-5d2f-e063-6394a90a053d",
"productndc": "73581-178",
"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": "Anti-Diarrheal/Anti-Gas Caplets",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA213484",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide Hydrochloride 2mg, Simethicone 125mg",
"start_marketing_date": "20210910",
"active_numerator_strength": "125; 2"
}Related drugs
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