FDA.reportPublic FDA data

aliskiren 300 MG Oral Tablet [Tekturna]

RxCUI
1011741
RxNorm name
aliskiren 300 MG Oral Tablet [Tekturna]
Display name
TEKTURNA (Oral Pill)
Full name
aliskiren 300 MG Oral Tablet [Tekturna]
Term type
SBD
Status
Active
Strength
300 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-26 03:52:56

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 hemifumarate300 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 300 MG Oral Tablet1NAMES
RxNorm Namealiskiren 300 MG Oral Tablet [Tekturna]1NAMES
RxNorm SynonymTekturna 300 MG Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID3dd61fa5-1620-4ebf-bbdb-ede29b92fce21CODES
RxCUI10117411CODES
MMSL_CODEBD192331CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
70839-300-3070839-300Tekturna aliskiren hemifumarateLXO US Inc.NDA021985

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA02198570839-300Tekturna aliskiren hemifumarateNDALXO US Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 14 matching rows.

NDC11, Source, Active table
NDC11SourceActive
50090298500rxnav_ndcsyes
70839030030rxnav_ndcsyes
00078048615rxnav_historical
00078048634rxnav_historical
00078048635rxnav_historical
00078048661rxnav_historical
17088006701rxnav_historical
50090125000rxnav_historical
54569627400rxnav_historical
54868604200rxnav_historical
66828002201rxnav_historical
70839030001rxnav_historical
70839030090rxnav_historical
70839030099rxnav_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): 70839-300-30
ndc (product): 70839-300
ndc11 (package): 70839030099
ndc11 (package): 70839030090
ndc11 (package): 70839030001
ndc11 (package): 70839030030
rxcui: 1011741

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 300 MG Oral Tablet [PSN] · aliskiren 300 MG Oral Tablet [Tekturna] [SBD] · Tekturna 300 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 300 MG Oral Tablet [PSN] · aliskiren 300 MG Oral Tablet [Tekturna] [SBD] · Tekturna 300 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
8bc4bed6-9a97-4aa1-b34d-6053bdb143a4These 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: 2007A-S Medication Solutions20240213
b7850390-719e-402b-b2cd-3400f83b4030These 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: 2007A-S Medication Solutions20171116
0b8af238-75c3-44b0-bc13-3ef9da0da7e5National Council for Prescription Drug Programs20120724
4a6d527e-99cf-4b45-8a93-3ebb024529caNational Council for Prescription Drug Programs20120724
5a817d82-6f92-4b11-bb18-dd7d2ed3278cNational Council for Prescription Drug Programs20120724
b05b15f2-a992-415d-a06a-6569251973a4National 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_STRENGTH300 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA021985
NAMESPrescribable SynonymTekturna 300 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon