🇺🇸
United States · US · US:64896-693_6163d9cc-fcc2-40a8-9b3d-0cce16b99b27
ALBENZA
Orange BookUNIISPLATC P02CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeP02CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1164896693492 TABLET, FILM COATED in 1 BOTTLE (64896-693-49)
Annotations
UNII (FDA Substance ID)
F4216019LN
ALBENDAZOLE
RxCUI 430
Orange Book
N020666
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "F4216019LN",
"rxcui": "430",
"inchikey": "HXHWSAZORRCQMX-UHFFFAOYSA-N",
"display_name": "ALBENDAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1977a867-0ee1-44c0-8da3-fe59c48699f5": {
"match": "brand_token",
"title": "ALBENZA (ALBENDAZOLE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]",
"spl_version": "14",
"published_date": "2024-10-25"
}
},
"productid": "64896-693_6163d9cc-fcc2-40a8-9b3d-0cce16b99b27",
"productndc": "64896-693",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020666",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Jun 11, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALBENDAZOLE",
"proprietary_name": "ALBENZA",
"active_ingred_unit": "mg/1",
"application_number": "NDA020666",
"marketing_category": "NDA",
"nonproprietary_name": "albendazole",
"start_marketing_date": "19960611",
"active_numerator_strength": "200"
}Related drugs
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