🇺🇸
United States · US · US:68391-224_16e8ebf2-bc1d-4930-9fd4-37258bfeaa6f
berkley and jensen anti diarrheal
Orange BookUNIISPLATC A07DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBJWC
CountryUS (United States)
ATC codeA07DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11683912246224 BLISTER PACK in 1 CARTON (68391-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A075232
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": {
"cda57e42-6106-46ee-82d1-479a692ee5bb": {
"match": "brand_token",
"title": "BERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [BJWC]",
"spl_version": "9",
"published_date": "2026-05-25"
}
},
"productid": "68391-224_16e8ebf2-bc1d-4930-9fd4-37258bfeaa6f",
"productndc": "68391-224",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "075232",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG",
"product_no": "001",
"approval_date": "Jan 6, 2000"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LOPERAMIDE HYDROCHLORIDE",
"proprietary_name": "berkley and jensen anti diarrheal",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075232",
"marketing_category": "ANDA",
"nonproprietary_name": "Loperamide Hydrochloride",
"start_marketing_date": "20030419",
"active_numerator_strength": "2"
}Related drugs
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