🇺🇸
United States · US · US:37808-714_09c4848d-0d0f-4400-97a9-8ae26913e540
anti diarrheal anti gas
Orange BookSPLATC P03AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerH E B
CountryUS (United States)
ATC codeP03AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11378087145312 BLISTER PACK in 1 CARTON (37808-714-53) / 1 TABLET in 1 BLISTER PACK
- ndc11378087146224 BLISTER PACK in 1 CARTON (37808-714-62) / 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": "37808-714_09c4848d-0d0f-4400-97a9-8ae26913e540",
"productndc": "37808-714",
"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 anti gas",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA209837",
"marketing_category": "ANDA",
"nonproprietary_name": "loperamide hydrochloride, simethicone",
"start_marketing_date": "20181115",
"active_numerator_strength": "125; 2"
}Related drugs
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