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United States · US · US:49884-424_6c3a1f0c-dd67-4849-a8b5-a88f85ac5f43
ALISKIREN
Orange BookUNIISPLATC C09XA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeC09XA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11498844241130 TABLET, FILM COATED in 1 BOTTLE (49884-424-11)
Annotations
UNII (FDA Substance ID)
C8A0P8G029
ALISKIREN HEMIFUMARATE
RxCUI 732498
Orange Book
A206665
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "C8A0P8G029",
"rxcui": "732498",
"inchikey": "KLRSDBSKUSSCGU-KRQUFFFQSA-N",
"display_name": "ALISKIREN HEMIFUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f3fd2503-25ef-4660-a29a-f62c491e28fb": {
"match": "brand_token",
"title": "ALISKIREN TABLET, FILM COATED [ENDO USA, INC.]",
"spl_version": "29",
"published_date": "2024-09-26"
}
},
"productid": "49884-424_6c3a1f0c-dd67-4849-a8b5-a88f85ac5f43",
"productndc": "49884-424",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206665",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "001",
"approval_date": "Mar 22, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 300MG BASE",
"product_no": "002",
"approval_date": "Mar 22, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALISKIREN HEMIFUMARATE",
"proprietary_name": "ALISKIREN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206665",
"marketing_category": "ANDA",
"nonproprietary_name": "ALISKIREN",
"start_marketing_date": "20190325",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code C09XA02.
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