FDA.reportPublic FDA data

aliskiren 300 MG Oral Tablet

RxCUI
1011739
RxNorm name
aliskiren 300 MG Oral Tablet
Display name
Aliskiren (Oral Pill)
Full name
aliskiren 300 MG Oral Tablet
Term type
SCD
Status
Active
Strength
300 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-26 03:52:52

RxNorm Status History#

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

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_STRaliskiren 300 MG Oral Tablet1NAMES
RxNorm Namealiskiren 300 MG Oral Tablet1NAMES
RxNorm Synonymaliskiren (as aliskiren fumarate) 300 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI10117391CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
49884-425-1149884-425ALISKIREN ALISKIRENPar Health USA, LLCANDA206665
66993-142-3066993-142Aliskiren aliskiren hemifumaratePrasco LaboratoriesNDA021985

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA20666549884-425ALISKIREN ALISKIRENANDAPar Health USA, LLC
NDA02198566993-142Aliskiren aliskiren hemifumarateNDA AUTHORIZED GENERICPrasco Laboratories

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 8 matching rows.

NDC11, Source, Active table
NDC11SourceActive
49884042511rxnav_ndcsyes
66993014230rxnav_ndcsyes
00078048615rxnav_historical_indirect
00078048634rxnav_historical_indirect
00078048635rxnav_historical_indirect
17088006701rxnav_historical_indirect
54868604200rxnav_historical_indirect
66828002201rxnav_historical_indirect

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 · 3 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
rxcui: 1011739
AliskirenALISKIREN HEMIFUMARATEPrasco Laboratories41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6db2023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 66993-142-30
ndc (product): 66993-142
ndc11 (package): 66993014230
rxcui: 1011739
ALISKIRENALISKIRENPar Health USA, LLCf3fd2503-25ef-4660-a29a-f62c491e28fb2022-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 49884-425-11
ndc (product): 49884-425
ndc11 (package): 49884042511
rxcui: 1011739

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 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f3fd2503-25ef-4660-a29a-f62c491e28fbaliskiren 300 MG Oral Tablet [PSN] · aliskiren 300 MG Oral Tablet [SCD] · aliskiren (as aliskiren fumarate) 300 MG Oral Tablet [SY]329These highlights do not include all the information needed to use ALISKIREN TABLETS safely and effectively. See full prescribing information for ALISKIREN TABLETS . ALISKIREN tablets , for oral use Initial U.S. Approval: 200720200924
41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6dbaliskiren 300 MG Oral Tablet [PSN] · aliskiren 300 MG Oral Tablet [SCD] · aliskiren (as aliskiren fumarate) 300 MG Oral Tablet [SY]318These highlights do not include all the information needed to use Aliskiren safely and effectively. See full prescribing information for Aliskiren. Aliskiren tablets, for oral use Initial U.S. Approval: 200720230501
3dd61fa5-1620-4ebf-bbdb-ede29b92fce2aliskiren 300 MG Oral Tablet [PSN] · aliskiren 300 MG Oral Tablet [SCD] · aliskiren (as aliskiren fumarate) 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-4336-8bf6-5628ddf24326aliskiren 300 MG Oral Tablet [PSN] · aliskiren 300 MG Oral Tablet [SCD] · aliskiren (as aliskiren fumarate) 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
41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6dbThese highlights do not include all the information needed to use Aliskiren safely and effectively. See full prescribing information for Aliskiren. Aliskiren tablets, for oral use Initial U.S. Approval: 2007Prasco Laboratories20230501
f3fd2503-25ef-4660-a29a-f62c491e28fbThese highlights do not include all the information needed to use ALISKIREN TABLETS safely and effectively. See full prescribing information for ALISKIREN TABLETS . ALISKIREN tablets , for oral use Initial U.S. Approval: 2007Par Health USA, LLC20221230
f3fd2503-25ef-4660-a29a-f62c491e28fbThese highlights do not include all the information needed to use ALISKIREN TABLETS safely and effectively. See full prescribing information for ALISKIREN TABLETS . ALISKIREN tablets , for oral use Initial U.S. Approval: 2007Endo USA, Inc.20200924
0b8af238-75c3-44b0-bc13-3ef9da0da7e5National Council for Prescription Drug Programs20120724
4a6d527e-99cf-4b45-8a93-3ebb024529caNational 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
CODESANDAANDA206665
CODESSNOMEDCT783030004
CODESVUID4025958
CODESVUID4025959
NAMESPrescribable Synonymaliskiren 300 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File