🇺🇸
United States · US · US:70839-300_130d24ec-4b3b-0978-e063-6394a90af0c8
Tekturna
Orange BookUNIISPLATC C09XA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLXO US Inc.
CountryUS (United States)
ATC codeC09XA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11708393003030 TABLET, FILM COATED in 1 BOTTLE (70839-300-30)
Annotations
UNII (FDA Substance ID)
C8A0P8G029
ALISKIREN HEMIFUMARATE
RxCUI 732498
Orange Book
N021985
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": {
"3dd61fa5-1620-4ebf-bbdb-ede29b92fce2": {
"match": "brand_token",
"title": "TEKTURNA (ALISKIREN HEMIFUMARATE) TABLET, FILM COATED [LXO US INC.]",
"spl_version": "16",
"published_date": "2024-03-12"
}
},
"productid": "70839-300_130d24ec-4b3b-0978-e063-6394a90af0c8",
"productndc": "70839-300",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021985",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "001",
"approval_date": "Mar 5, 2007"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 300MG BASE",
"product_no": "002",
"approval_date": "Mar 5, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALISKIREN HEMIFUMARATE",
"proprietary_name": "Tekturna",
"active_ingred_unit": "mg/1",
"application_number": "NDA021985",
"marketing_category": "NDA",
"nonproprietary_name": "aliskiren hemifumarate",
"start_marketing_date": "20070305",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code C09XA02.
Access this data programmatically
Query Tekturna and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.