FDA.reportPublic FDA data

Tekturna HCT

Product NDC
70839-125
11-digit product format
708390125
Labeler code
70839
Product ID
70839-125_ed9274e4-086a-0713-e053-2a95a90ae88d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aliskiren hemifumarate and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Noden Pharma USA, Inc.
Application
NDA022107
Marketing category
NDA
Marketing start
2008-08-01
Marketing end
0000-00-00
Substance
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
Active strength
150 mg/1; mg/1
Pharmacologic classes
Increased Diuresis [PE], Renin Inhibitor [EPC], Renin Inhibitors [MoA], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
d42d9045-7020-6e5a-1a1f-b86d9a92bc22Product name320201015
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70839-125-012024-01-30C16284748780-11030e365-6576-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TEKTURNA HCT safely and effectively. See full prescribing information for TEKTURNA HCT. TEKTURNA ® HCT (aliskiren and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 2008
70839-125-302024-01-30C16284748780-11030e365-6576-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TEKTURNA HCT safely and effectively. See full prescribing information for TEKTURNA HCT. TEKTURNA ® HCT (aliskiren and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 2008
70839-125-902024-01-30C16284748780-11030e365-6576-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TEKTURNA HCT safely and effectively. See full prescribing information for TEKTURNA HCT. TEKTURNA ® HCT (aliskiren and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70839-125-01Tekturna HCT1 in 1 BLISTER PACKTABLET, FILM COATED111
70839-125-01Tekturna HCT100 in 1 PACKAGETABLET, FILM COATED10011
70839-125-30Tekturna HCT30 in 1 BOTTLETABLET, FILM COATED3011
70839-125-90Tekturna HCT90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70839-125-30EA - Each70839-1258031b5e7-6a8a-4b77-8be0-f3294b88be1012017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70839-125TEKTURNA HCT (ALISKIREN HEMIFUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NODEN PHARMA USA, INC.]11Legacy NDC, 4 package rows20221117_8df0ca6a-58cf-41fc-b890-5c7fa5a3792c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011710aliskiren 150 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011713aliskiren 150 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011750aliskiren 300 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011753aliskiren 300 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011712Tekturna HCT 150 MG / 12.5 MG Oral TabletPSN8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011715Tekturna HCT 150 MG / 25 MG Oral TabletPSN8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011752Tekturna HCT 300 MG / 12.5 MG Oral TabletPSN8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011755Tekturna HCT 300 MG / 25 MG Oral TabletPSN8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011712aliskiren 150 MG / hydrochlorothiazide 12.5 MG Oral Tablet [Tekturna HCT]SBD8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011715aliskiren 150 MG / hydrochlorothiazide 25 MG Oral Tablet [Tekturna HCT]SBD8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011752aliskiren 300 MG / hydrochlorothiazide 12.5 MG Oral Tablet [Tekturna HCT]SBD8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011755aliskiren 300 MG / hydrochlorothiazide 25 MG Oral Tablet [Tekturna HCT]SBD8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011710aliskiren 150 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011713aliskiren 150 MG / hydrochlorothiazide 25 MG Oral TabletSCD8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011750aliskiren 300 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011753aliskiren 300 MG / hydrochlorothiazide 25 MG Oral TabletSCD8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011710aliskiren 150 MG / HCTZ 12.5 MG Oral TabletSY8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011712aliskiren 150 MG / HCTZ 12.5 MG Oral Tablet [Tekturna HCT]SY8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011713aliskiren 150 MG / HCTZ 25 MG Oral TabletSY8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011715aliskiren 150 MG / HCTZ 25 MG Oral Tablet [Tekturna HCT]SY8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011750aliskiren 300 MG / HCTZ 12.5 MG Oral TabletSY8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011752aliskiren 300 MG / HCTZ 12.5 MG Oral Tablet [Tekturna HCT]SY8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011753aliskiren 300 MG / HCTZ 25 MG Oral TabletSY8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011755aliskiren 300 MG / HCTZ 25 MG Oral Tablet [Tekturna HCT]SY8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011712Tekturna HCT (aliskiren 150 MG / HCTZ 12.5 MG) Oral TabletSY8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011715Tekturna HCT (aliskiren 150 MG / HCTZ 25 MG) Oral TabletSY8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011752Tekturna HCT (aliskiren 300 MG / HCTZ 12.5 MG) Oral TabletSY8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11
1011755Tekturna HCT (aliskiren 300 MG / HCTZ 25 MG) Oral TabletSY8df0ca6a-58cf-41fc-b890-5c7fa5a3792c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70839-125-01708390125011 in 1 BLISTER PACKHistorical
70839-125-307083901253030 TABLET, FILM COATED in 1 BOTTLE (70839-125-30) 2017-01-010000-00-00NoNoCurrent
70839-125-907083901259090 in 1 BOTTLEHistorical