Tekturna is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Noden Pharma Usa, Inc.. The primary component is Aliskiren Hemifumarate.
Product ID | 70839-150_41dc5660-c40e-42b3-b283-bd315c469048 |
NDC | 70839-150 |
Product Type | Human Prescription Drug |
Proprietary Name | Tekturna |
Generic Name | Aliskiren Hemifumarate |
Dosage Form | Tablet, Film Coated |
Route of Administration | ORAL |
Marketing Start Date | 2007-03-05 |
Marketing Category | NDA / NDA |
Application Number | NDA021985 |
Labeler Name | Noden Pharma USA, Inc. |
Substance Name | ALISKIREN HEMIFUMARATE |
Active Ingredient Strength | 150 mg/1 |
Pharm Classes | Renin Inhibitor [EPC],Renin Inhibitors [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2017-01-01 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA021985 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2017-01-01 |
Marketing End Date | 2017-01-01 |
Marketing Category | NDA |
Application Number | NDA021985 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2017-01-01 |
Marketing Category | NDA |
Application Number | NDA021985 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2017-01-01 |
Marketing End Date | 2017-01-01 |
Marketing Category | NDA |
Application Number | NDA021985 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2017-12-12 |
Marketing End Date | 2019-05-31 |
Ingredient | Strength |
---|---|
ALISKIREN HEMIFUMARATE | 150 mg/1 |
SPL SET ID: | 3dd61fa5-1620-4ebf-bbdb-ede29b92fce2 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
NDC | Brand Name | Generic Name |
---|---|---|
50090-1250 | Tekturna | aliskiren hemifumarate |
50090-2985 | Tekturna | aliskiren hemifumarate |
70839-150 | Tekturna | aliskiren hemifumarate |
70839-300 | Tekturna | aliskiren hemifumarate |
66993-141 | Aliskiren | aliskiren hemifumarate |
66993-142 | Aliskiren | aliskiren hemifumarate |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TEKTURNA 79001021 2951884 Live/Registered |
Noden Pharma DAC 2004-01-07 |
TEKTURNA 77022705 3799883 Live/Registered |
NODEN PHARMA DAC 2006-10-17 |