FDA.reportPublic FDA data

aliskiren 150 MG Oral Tablet [Tekturna]

RxCUI
1011738
RxNorm name
aliskiren 150 MG Oral Tablet [Tekturna]
Display name
TEKTURNA (Oral Pill)
Full name
aliskiren 150 MG Oral Tablet [Tekturna]
Term type
SBD
Status
Active
Strength
150 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-26 03:52:50

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
102010
Active start
102010
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
aliskiren hemifumarate150 MG / 1 EACHaliskirenaliskiren

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
aliskiren325646

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRTekturna 150 MG Oral Tablet1NAMES
RxNorm Namealiskiren 150 MG Oral Tablet [Tekturna]1NAMES
RxNorm SynonymTekturna 150 MG Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID3dd61fa5-1620-4ebf-bbdb-ede29b92fce21CODES
RxCUI10117381CODES
MMSL_CODEBD192321CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
70839-150-3070839-150Tekturna aliskiren hemifumarateLXO US Inc.NDA021985

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA02198570839-150Tekturna aliskiren hemifumarateNDALXO US Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 17 matching rows.

NDC11, Source, Active table
NDC11SourceActive
70839015030rxnav_ndcsyes
00078048515rxnav_historical
00078048534rxnav_historical
00078048535rxnav_historical
00078048561rxnav_historical
12280040030rxnav_historical_indirect
17088006601rxnav_historical
35356013330rxnav_historical
51129427001rxnav_historical
51129427002rxnav_historical
54569627300rxnav_historical
54868577200rxnav_historical
66828002101rxnav_historical
69189048501rxnav_historical
70839015001rxnav_historical
70839015090rxnav_historical
70839015099rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TekturnaALISKIREN HEMIFUMARATELXO US Inc.3dd61fa5-1620-4ebf-bbdb-ede29b92fce22024-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 70839-150-30
ndc (product): 70839-150
ndc11 (package): 70839015001
ndc11 (package): 70839015099
ndc11 (package): 70839015030
ndc11 (package): 70839015090
rxcui: 1011738

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3dd61fa5-1620-4ebf-bbdb-ede29b92fce2Tekturna 150 MG Oral Tablet [PSN] · aliskiren 150 MG Oral Tablet [Tekturna] [SBD] · Tekturna 150 MG Oral Tablet [SY]316These highlights do not include all the information needed to use TEKTURNA safely and effectively. See full prescribing information for TEKTURNA. TEKTURNA ® (aliskiren) tablets, for oral use Initial U.S. Approval: 200720240307
4c222831-90af-4336-8bf6-5628ddf24326Tekturna 150 MG Oral Tablet [PSN] · aliskiren 150 MG Oral Tablet [Tekturna] [SBD] · Tekturna 150 MG Oral Tablet [SY]32These highlights do not include all the information needed to use TEKTURNA ® safely and effectively. See full prescribing information for TEKTURNA ® . Tekturna ® (aliskiren) tablets, for oral use Initial U.S. Approval: 200 720120113

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
3dd61fa5-1620-4ebf-bbdb-ede29b92fce2These highlights do not include all the information needed to use TEKTURNA safely and effectively. See full prescribing information for TEKTURNA. TEKTURNA ® (aliskiren) tablets, for oral use Initial U.S. Approval: 2007LXO US Inc. | Packaging Coordinators, LLC | Delpharm Milano S.r.l.20240307
02f2d79f-b896-44b7-a6ba-3ab28ddad0f2National Council for Prescription Drug Programs20120724
3bea8b5c-0b1e-4e5f-b614-14a4d5414430National Council for Prescription Drug Programs20120724
720b7811-4d0d-4f2e-b44f-3cf2f3d37434National Council for Prescription Drug Programs20120724
9b7a8fa4-3518-47b3-85bc-3c531bd1e352National Council for Prescription Drug Programs20120724
4c222831-90af-4336-8bf6-5628ddf24326These highlights do not include all the information needed to use TEKTURNA ® safely and effectively. See full prescribing information for TEKTURNA ® . Tekturna ® (aliskiren) tablets, for oral use Initial U.S. Approval: 200 7Physicians Total Care, Inc.20120113

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC09XARenin-inhibitorsATC1-4aliskiren
FDASPLN0000175900Renin InhibitorEPChas_epcaliskiren
FDASPLN0000175899Renin InhibitorsMOAhas_moaaliskiren
MEDRTD000577AmidesCHEMhas_ingredientaliskiren
MEDRTD005650FumaratesCHEMhas_ingredientaliskiren
MEDRTD013449SulfonamidesCHEMci_chemclassaliskiren
MEDRTD001002AnuriaDISEASEci_withaliskiren
MEDRTD002675Child, PreschoolDISEASEci_withaliskiren
MEDRTD003920Diabetes MellitusDISEASEci_withaliskiren
MEDRTD006967HypersensitivityDISEASEci_withaliskiren
MEDRTD006973HypertensionDISEASEmay_treataliskiren
MEDRTN0000000181Angiotensin-converting Enzyme InhibitorsMOAci_moaaliskiren
MEDRTN0000000181Angiotensin-converting Enzyme InhibitorsMOAhas_moaaliskiren
MEDRTN0000175899Renin InhibitorsMOAci_moaaliskiren
MEDRTN0000175899Renin InhibitorsMOAhas_moaaliskiren
MEDRTN0000178477Decreased Blood PressurePEhas_pealiskiren

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH150 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA021985
NAMESPrescribable SynonymTekturna 150 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon