tekturna

Generic: aliskiren hemifumarate

Labeler: lxo us inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tekturna
Generic Name aliskiren hemifumarate
Labeler lxo us inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

aliskiren hemifumarate 150 mg/1

Manufacturer
LXO US Inc.

Identifiers & Regulatory

Product NDC 70839-150
Product ID 70839-150_130d24ec-4b3b-0978-e063-6394a90af0c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021985
Listing Expiration 2026-12-31
Marketing Start 2007-03-05

Pharmacologic Class

Classes
renin inhibitor [epc] renin inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70839150
Hyphenated Format 70839-150

Supplemental Identifiers

RxCUI
1011736 1011738 1011739 1011741
UPC
0370839300306
UNII
C8A0P8G029

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tekturna (source: ndc)
Generic Name aliskiren hemifumarate (source: ndc)
Application Number NDA021985 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (70839-150-30)
source: ndc

Packages (1)

70839-150-30 30 TABLET, FILM COATED in 1 BOTTLE (70839-150-30)

Ingredients (1)

aliskiren hemifumarate (150 mg/1)

Linked Drug Pages (1)

Tekturna ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "130d24ec-4b3b-0978-e063-6394a90af0c8", "openfda": {"upc": ["0370839300306"], "unii": ["C8A0P8G029"], "rxcui": ["1011736", "1011738", "1011739", "1011741"], "spl_set_id": ["3dd61fa5-1620-4ebf-bbdb-ede29b92fce2"], "manufacturer_name": ["LXO US Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70839-150-30)", "package_ndc": "70839-150-30", "marketing_start_date": "20170101"}], "brand_name": "Tekturna", "product_id": "70839-150_130d24ec-4b3b-0978-e063-6394a90af0c8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Renin Inhibitor [EPC]", "Renin Inhibitors [MoA]"], "product_ndc": "70839-150", "generic_name": "aliskiren hemifumarate", "labeler_name": "LXO US Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tekturna", "active_ingredients": [{"name": "ALISKIREN HEMIFUMARATE", "strength": "150 mg/1"}], "application_number": "NDA021985", "marketing_category": "NDA", "marketing_start_date": "20070305", "listing_expiration_date": "20261231"}