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United States · US · US:69842-644_927820f7-afd0-4433-9202-86729b523a61
anti diarrheal and anti gas
Orange BookSPLATC P03AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCVS Pharmacy
CountryUS (United States)
ATC codeP03AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11698426445312 BLISTER PACK in 1 CARTON (69842-644-53) / 1 TABLET in 1 BLISTER PACK
- ndc11698426446224 BLISTER PACK in 1 CARTON (69842-644-62) / 1 TABLET in 1 BLISTER PACK
Annotations
Orange Book
A209837
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"dd993f38-a31f-4739-9496-e14186a89053": {
"match": "brand_token",
"title": "ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION, INC.]",
"spl_version": "6",
"published_date": "2026-05-21"
}
},
"productid": "69842-644_927820f7-afd0-4433-9202-86729b523a61",
"productndc": "69842-644",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209837",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG;125MG",
"product_no": "001",
"approval_date": "Sep 5, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIMETHICONE; LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "anti diarrheal and anti gas",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA209837",
"marketing_category": "ANDA",
"nonproprietary_name": "loperamide hydrochloride, simethicone",
"start_marketing_date": "20190806",
"active_numerator_strength": "125; 2"
}Related drugs
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