Product NDC: | 54868-6103 |
Proprietary Name: | Tekturna HCT |
Non Proprietary Name: | aliskiren hemifumarate and hydrochlorothiazide |
Active Ingredient(s): | 300; 12.5 mg/1; mg/1 & nbsp; aliskiren hemifumarate and hydrochlorothiazide |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54868-6103 |
Labeler Name: | Physicians Total Care, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022107 |
Marketing Category: | NDA |
Start Marketing Date: | 20100413 |
Package NDC: | 54868-6103-0 |
Package Description: | 90 TABLET, FILM COATED in 1 BOTTLE (54868-6103-0) |
NDC Code | 54868-6103-0 |
Proprietary Name | Tekturna HCT |
Package Description | 90 TABLET, FILM COATED in 1 BOTTLE (54868-6103-0) |
Product NDC | 54868-6103 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | aliskiren hemifumarate and hydrochlorothiazide |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20100413 |
Marketing Category Name | NDA |
Labeler Name | Physicians Total Care, Inc. |
Substance Name | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE |
Strength Number | 300; 12.5 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] |