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United States · US · US:50844-735_cb21f56f-f513-4fa1-817c-0e5c3ce660c5
Loperamide HCl
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerL.N.K. International, Inc.
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc1150844735022 BLISTER PACK in 1 CARTON (50844-735-02) / 6 TABLET in 1 BLISTER PACK
- ndc1150844735084 BLISTER PACK in 1 CARTON (50844-735-08) / 6 TABLET in 1 BLISTER PACK
- ndc1150844735192 BLISTER PACK in 1 CARTON (50844-735-19) / 4 TABLET in 1 BLISTER PACK
- ndc1150844735241 BLISTER PACK in 1 CARTON (50844-735-24) / 2 TABLET in 1 BLISTER PACK
- ndc1150844735443 BLISTER PACK in 1 CARTON (50844-735-44) / 6 TABLET in 1 BLISTER PACK
- ndc1150844735451 BLISTER PACK in 1 CARTON (50844-735-45) / 6 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A076497
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "77TI35393C",
"rxcui": "82038",
"inchikey": "PGYPOBZJRVSMDS-UHFFFAOYSA-N",
"display_name": "LOPERAMIDE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"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": "50844-735_cb21f56f-f513-4fa1-817c-0e5c3ce660c5",
"productndc": "50844-735",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076497",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG",
"product_no": "001",
"approval_date": "Jun 10, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "Loperamide HCl",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076497",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide HCl",
"start_marketing_date": "20050503",
"active_numerator_strength": "2"
}Related drugs
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