aliskiren ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
renin inhibitors 119 173334-57-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • aliskiren
  • rasilez
  • tekturna
  • aliskiren hemifumarate
  • aliskiren fumarate
  • SPP100
Renin is secreted by the kidney in response to decreases in blood volume and renal perfusion. Renin cleaves angiotensinogen to form the inactive decapeptide angiotensin I (Ang I). Ang I is converted to the active octapeptide angiotensin II (Ang II) by ACE and non-ACE pathways. Ang II is a powerful vasoconstrictor and leads to the release of catecholamines from the adrenal medulla and prejunctional nerve endings. It also promotes aldosterone secretion and sodium reabsorption. Together, these effects increase blood pressure. Ang II also inhibits renin release, thus providing a negative feedback to the system. This cycle, from renin through angiotensin to aldosterone and its associated negative feedback loop, is known as the renin-angiotensin-aldosterone system (RAAS). Aliskiren is a direct renin inhibitor, decreasing plasma renin activity (PRA) and inhibiting the conversion of angiotensinogen to Ang I. Whether aliskiren affects other RAAS components, e.g., ACE or non-ACE pathways, is not known.
  • Molecular weight: 551.77
  • Formula: C30H53N3O6
  • CLOGP: 3.51
  • LIPINSKI: 1
  • HAC: 9
  • HDO: 4
  • TPSA: 146.13
  • ALOGS: -5.42
  • ROTB: 19

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.15 g O

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 7.77 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Hosey CM, Chan R, Benet LZ
S (Water solubility) 100 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 25 % Hosey CM, Chan R, Benet LZ
BA (Bioavailability) 2.50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,NTRK2,PDK2,PDK4,PRKDC,TEK,TGFBR1 18
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 4.467 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
rat-kpuu-brain Rat brain Kpuu 0.009 % High 1

Approvals:

DateAgencyCompanyOrphan
March 5, 2007 FDA NOVARTIS
Aug. 22, 2007 EMA Noden Pharma DAC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Personality disorder 879.09 32.15 238 15893 12206 90600110
Neurologic neglect syndrome 874.72 32.15 221 15910 8626 90603690
Carotid artery thrombosis 868.73 32.15 221 15910 8871 90603445
Adjustment disorder 836.40 32.15 217 15914 9425 90602891
Hemiplegia 817.55 32.15 238 15893 15922 90596394
Affect lability 795.71 32.15 239 15892 17824 90594492
Sensory loss 748.26 32.15 228 15903 17847 90594469
Motor dysfunction 704.96 32.15 221 15910 19009 90593307
Coordination abnormal 686.24 32.15 222 15909 21134 90591182
Hemiparesis 640.34 32.15 233 15898 31586 90580730
Muscle spasticity 634.80 32.15 238 15893 35084 90577232
Eating disorder 615.31 32.15 219 15912 27854 90584462
Aphasia 611.16 32.15 244 15887 42568 90569748
Dysarthria 531.81 32.15 237 15894 54245 90558071
Cerebrovascular accident 477.07 32.15 288 15843 123245 90489071
Skin haemorrhage 454.04 32.15 163 15968 21217 90591099
Arterial occlusive disease 451.61 32.15 142 15989 12304 90600012
Gangrene 442.73 32.15 141 15990 12735 90599581
Dysphagia 421.15 32.15 257 15874 112021 90500295
Sinus congestion 404.00 32.15 160 15971 27264 90585052
Sneezing 390.76 32.15 160 15971 29709 90582607
Respiratory tract congestion 383.19 32.15 154 15977 27256 90585060
Sinus disorder 368.75 32.15 160 15971 34287 90578029
Angina pectoris 339.67 32.15 157 15974 39003 90573313
Skin exfoliation 279.08 32.15 165 15966 67748 90544568
Cystitis 273.91 32.15 162 15969 66556 90545760
Muscular weakness 265.37 32.15 249 15882 206417 90405899
Blood pressure inadequately controlled 263.67 32.15 80 16051 6144 90606172
Influenza like illness 243.28 32.15 161 15970 80450 90531866
Rhinorrhoea 232.28 32.15 162 15969 88154 90524162
Cataract 217.54 32.15 144 15987 71948 90540368
Blood pressure increased 216.26 32.15 218 15913 196999 90415317
Anxiety 198.11 32.15 259 15872 309513 90302803
Palpitations 166.22 32.15 160 15971 136568 90475748
Influenza 163.73 32.15 160 15971 139104 90473212
Chest discomfort 159.00 32.15 157 15974 138208 90474108
Psoriasis 150.35 32.15 157 15974 147597 90464719
Confusional state 146.47 32.15 253 15878 385952 90226364
Diabetes mellitus inadequate control 143.70 32.15 69 16062 18615 90593701
Conjoined twins 131.53 32.15 28 16103 502 90611814
Exercise tolerance decreased 128.63 32.15 49 16082 7502 90604814
Fall 121.88 32.15 266 15865 481544 90130772
Arthritis 111.55 32.15 143 15988 167172 90445144
Multiple drug therapy 103.49 32.15 41 16090 6968 90605348
Truncus arteriosus persistent 87.18 32.15 19 16112 382 90611934
Off label use 87.14 32.15 44 16087 1102208 89510108
Congenital cardiovascular anomaly 77.74 32.15 18 16113 480 90611836
Cough 76.93 32.15 189 15942 368773 90243543
Intestinal malrotation 74.32 32.15 17 16114 429 90611887
Congenital bladder anomaly 73.41 32.15 15 16116 218 90612098
Angioedema 73.28 32.15 73 16058 64803 90547513
Urachal abnormality 72.91 32.15 15 16116 226 90612090
Persistent cloaca 72.12 32.15 15 16116 239 90612077
Asthenia 69.83 32.15 231 15900 533520 90078796
Arthralgia 67.80 32.15 27 16104 778495 89833821
Gastrointestinal disorder 66.15 32.15 143 15988 256544 90355772
Cardiac septal defect 64.77 32.15 17 16114 768 90611548
Impaired work ability 64.09 32.15 41 16090 19285 90593031
Drug intolerance 63.88 32.15 4 16127 447587 90164729
Concomitant disease progression 62.73 32.15 21 16110 2211 90610105
Infusion related reaction 58.66 32.15 4 16127 416776 90195540
Heart disease congenital 56.40 32.15 18 16113 1631 90610685
Condition aggravated 56.33 32.15 18 16113 595527 90016789
Joint swelling 53.65 32.15 12 16119 503288 90109028
Arthropathy 50.14 32.15 4 16127 366238 90246078
Sinusitis 49.78 32.15 154 15977 342934 90269382
Hepatic enzyme increased 49.22 32.15 4 16127 360732 90251584
Abortion induced 49.05 32.15 29 16102 11859 90600457
Alopecia 46.73 32.15 15 16116 495056 90117260
Nasopharyngitis 45.18 32.15 167 15964 406937 90205379
Rheumatoid arthritis 42.12 32.15 151 15980 362463 90249853
Depressed mood 41.66 32.15 48 16083 50174 90562142
Toxicity to various agents 39.79 32.15 3 16128 287843 90324473
Hypersensitivity 39.12 32.15 16 16115 454661 90157655
Ventricular septal defect 38.65 32.15 19 16112 5388 90606928
Product use in unapproved indication 37.91 32.15 7 16124 336229 90276087
Malaise 37.46 32.15 204 15927 585782 90026534
Swelling 37.28 32.15 14 16117 419044 90193272
Treatment noncompliance 37.25 32.15 46 16085 51681 90560635
Cognitive disorder 35.14 32.15 52 16079 69355 90542961
Stomatitis 34.94 32.15 4 16127 274694 90337622
Rash 34.88 32.15 55 16076 796045 89816271
Hyperkalaemia 34.82 32.15 50 16081 64914 90547402
Anal prolapse 34.70 32.15 7 16124 95 90612221
Periumbilical abscess 34.35 32.15 8 16123 219 90612097
Blister 34.29 32.15 3 16128 254995 90357321
Pruritus 33.92 32.15 28 16103 541497 90070819
Musculoskeletal stiffness 33.80 32.15 6 16125 296526 90315790
Catheter site abscess 33.42 32.15 8 16123 247 90612069
Contraindicated product administered 33.35 32.15 8 16123 320131 90292185
Drug ineffective 32.42 32.15 132 15999 1384166 89228150

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Concomitant disease progression 304.93 21.16 68 4793 2435 42614039
Blood creatinine increased 100.51 21.16 90 4771 109913 42506561
Hyperkalaemia 90.08 21.16 74 4787 80384 42536090
Blood pressure inadequately controlled 58.54 21.16 19 4842 2849 42613625
Chronic kidney disease 51.85 21.16 43 4818 47198 42569276
Renal impairment 51.37 21.16 63 4798 110165 42506309
Angina pectoris 47.01 21.16 35 4826 32861 42583613
Urine albumin/creatinine ratio increased 46.15 21.16 11 4850 527 42615947
Off label use 43.36 21.16 10 4851 638325 41978149
Blood pressure increased 42.30 21.16 55 4806 101873 42514601
Blood potassium increased 41.42 21.16 26 4835 18510 42597964
Bundle branch block left 37.08 21.16 17 4844 6459 42610015
Oedema peripheral 34.17 21.16 58 4803 136018 42480456
Diabetic nephropathy 33.95 21.16 12 4849 2329 42614145
Glycosylated haemoglobin increased 33.66 21.16 20 4841 12904 42603570
Hypotension 32.87 21.16 83 4778 257548 42358926
Post procedural haematoma 30.08 21.16 10 4851 1615 42614859
Angioedema 29.61 21.16 30 4831 42447 42574027
Disease progression 29.37 21.16 56 4805 143600 42472874
Dyspnoea 28.94 21.16 113 4748 442508 42173966
Syncope 28.49 21.16 45 4816 99361 42517113
Cardiac failure chronic 28.03 21.16 16 4845 9585 42606889
Bundle branch block right 27.74 21.16 15 4846 8091 42608383
Cardiac failure acute 27.67 21.16 18 4843 13615 42602859
Orthopnoea 27.24 21.16 13 4848 5404 42611070
Renal failure 26.92 21.16 54 4807 143672 42472802
Acute pulmonary oedema 26.83 21.16 15 4846 8636 42607838
Blood urea increased 26.28 21.16 25 4836 32768 42583706
Myocardial ischaemia 23.37 21.16 18 4843 17744 42598730
Oedema 23.01 21.16 29 4832 51972 42564502
Defect conduction intraventricular 22.23 21.16 6 4855 475 42615999
Atrioventricular block first degree 22.18 21.16 12 4849 6479 42609995
Sudden cardiac death 21.52 21.16 10 4851 3914 42612560
Cerebral arteriosclerosis 21.18 21.16 6 4855 568 42615906

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Personality disorder 900.94 28.26 242 18578 12595 110557884
Neurologic neglect syndrome 893.29 28.26 225 18595 9073 110561406
Carotid artery thrombosis 890.20 28.26 226 18594 9412 110561067
Adjustment disorder 840.70 28.26 221 18599 10574 110559905
Affect lability 811.69 28.26 242 18578 18395 110552084
Hemiplegia 759.64 28.26 241 18579 22541 110547938
Sensory loss 727.89 28.26 230 18590 21227 110549252
Coordination abnormal 679.33 28.26 227 18593 25001 110545478
Motor dysfunction 678.69 28.26 225 18595 24181 110546298
Muscle spasticity 655.84 28.26 242 18578 35673 110534806
Eating disorder 619.47 28.26 223 18597 30635 110539844
Hemiparesis 591.18 28.26 237 18583 43666 110526813
Aphasia 558.85 28.26 248 18572 58749 110511730
Dysarthria 466.51 28.26 245 18575 83876 110486603
Arterial occlusive disease 449.01 28.26 147 18673 15161 110555318
Skin haemorrhage 444.63 28.26 165 18655 24662 110545817
Gangrene 435.61 28.26 146 18674 16195 110554284
Sinus congestion 408.38 28.26 164 18656 30295 110540184
Sneezing 404.04 28.26 165 18655 31819 110538660
Sinus disorder 396.98 28.26 164 18656 32564 110537915
Respiratory tract congestion 385.73 28.26 158 18662 30699 110539780
Dysphagia 378.81 28.26 266 18554 153334 110417145
Cerebrovascular accident 374.53 28.26 282 18538 181002 110389477
Angina pectoris 335.45 28.26 178 18642 62117 110508362
Concomitant disease progression 295.76 28.26 77 18743 3533 110566946
Cystitis 287.47 28.26 164 18656 65872 110504607
Skin exfoliation 251.93 28.26 167 18653 87484 110482995
Blood pressure inadequately controlled 251.10 28.26 80 18740 7553 110562926
Influenza like illness 243.39 28.26 164 18656 88248 110482231
Muscular weakness 239.49 28.26 251 18569 248217 110322262
Rhinorrhoea 225.79 28.26 166 18654 102500 110467979
Cataract 224.92 28.26 150 18670 79335 110491144
Blood pressure increased 210.60 28.26 239 18581 258134 110312345
Anxiety 186.64 28.26 260 18560 344818 110225661
Psoriasis 169.04 28.26 160 18660 139833 110430646
Influenza 150.67 28.26 164 18656 168937 110401542
Palpitations 149.92 28.26 159 18661 159053 110411426
Chest discomfort 148.66 28.26 165 18655 173683 110396796
Arthritis 121.31 28.26 146 18674 167440 110403039
Confusional state 120.79 28.26 254 18566 468426 110102053
Diabetes mellitus inadequate control 118.98 28.26 70 18750 29705 110540774
Off label use 118.50 28.26 54 18766 1500131 109070348
Fall 115.73 28.26 291 18529 603191 109967288
Exercise tolerance decreased 108.55 28.26 49 18771 12018 110558461
Multiple drug therapy 99.94 28.26 41 18779 7973 110562506
Gastrointestinal disorder 90.66 28.26 154 18666 241798 110328681
Cough 82.55 28.26 217 18603 461424 110109055
Sinusitis 70.77 28.26 156 18664 296532 110273947
Condition aggravated 68.69 28.26 20 18800 734816 109835663
Asthenia 68.10 28.26 264 18556 688735 109881744
Rheumatoid arthritis 67.50 28.26 154 18666 299459 110271020
Hyperkalaemia 65.40 28.26 97 18723 135699 110434780
Nasopharyngitis 64.05 28.26 179 18641 394182 110176297
Toxicity to various agents 57.72 28.26 7 18813 480548 110089931
Angioedema 57.26 28.26 77 18743 98423 110472056
Impaired work ability 54.16 28.26 41 18779 26378 110544101
Neutropenia 48.77 28.26 4 18816 374616 110195863
Product use in unapproved indication 48.04 28.26 9 18811 447368 110123111
Amaurosis fugax 46.87 28.26 17 18803 2373 110568106
Infusion related reaction 44.68 28.26 6 18814 381156 110189323
Malaise 44.06 28.26 228 18592 671591 109898888
Rash 42.84 28.26 46 18774 820918 109749561
Hypersensitivity 41.55 28.26 9 18811 403989 110166490
Drug intolerance 38.04 28.26 11 18809 406501 110163978
Febrile neutropenia 37.08 28.26 5 18815 316762 110253717
Anal prolapse 36.71 28.26 7 18813 73 110570406
Joint swelling 36.25 28.26 15 18805 442830 110127649
Arthralgia 36.07 28.26 48 18772 779584 109790895
Depressed mood 36.04 28.26 48 18772 60761 110509718
Alopecia 35.77 28.26 9 18811 364744 110205735
Arthropathy 34.97 28.26 4 18816 287518 110282961
Stomatitis 34.85 28.26 3 18817 270239 110300240
Blood creatinine increased 34.67 28.26 88 18732 182801 110387678
Drug ineffective 34.40 28.26 138 18682 1520402 109050077
Diabetic nephropathy 33.96 28.26 15 18805 3493 110566986
Hepatic enzyme increased 33.29 28.26 7 18813 320885 110249594
Catheter site abscess 33.09 28.26 8 18812 270 110570209
Periumbilical abscess 32.02 28.26 8 18812 310 110570169
Product dose omission issue 31.43 28.26 8 18812 321774 110248705
Cognitive disorder 29.21 28.26 53 18767 87458 110483021
Oedema peripheral 29.20 28.26 122 18698 328538 110241941
Wound 29.17 28.26 3 18817 234434 110336045
Diarrhoea 28.60 28.26 99 18721 1139406 109431073

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C09DX02 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09XA02 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Renin-inhibitors
ATC C09XA52 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Renin-inhibitors
ATC C09XA53 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Renin-inhibitors
ATC C09XA54 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Renin-inhibitors
MeSH PA D000092502 Renin Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D011480 Protease Inhibitors
FDA MoA N0000175899 Renin Inhibitors
FDA EPC N0000175900 Renin Inhibitor
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:145947 antiatherosclerotic agent
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

C09DX Angiotensin II receptor blockers (ARBs), other combinations 10 drugs
C09XA Renin-inhibitors 3 drugs

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Anuria contraindication 2472002 DOID:2983
Hypercholesterolemia contraindication 13644009
Hyperkalemia contraindication 14140009
Secondary angle-closure glaucoma contraindication 21571006
Hypovolemia contraindication 28560003
Obstruction of bile duct contraindication 30144000
Dehydration contraindication 34095006
Hyperuricemia contraindication 35885006 DOID:1920
Angioedema contraindication 41291007 DOID:1558
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Hypochloremic alkalosis contraindication 70134007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Chronic idiopathic constipation contraindication 82934008
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Neutropenic disorder contraindication 303011007 DOID:1227
Azotemia contraindication 445009001
Severe Aortic Valve Stenosis contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.53 acidic
pKa2 9.2 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Renin Enzyme INHIBITOR IC50 9.22 WOMBAT-PK CHEMBL
Multidrug resistance protein 1 Transporter Km 5.68 WOMBAT-PK
Cytochrome P450 3A4 Enzyme Km 4.61 WOMBAT-PK
Renin Enzyme IC50 8.70 CHEMBL
Renin Enzyme IC50 8.10 CHEMBL
Renin Enzyme IC50 7.10 CHEMBL
Renin-1 Enzyme IC50 8.35 CHEMBL
Renin Enzyme IC50 7.96 CHEMBL
Protease Enzyme Ki 7.12 CHEMBL
Renin Enzyme IC50 8.92 CHEMBL

External reference:

IDSource
4025960 VUID
N0000179765 NUI
D03208 KEGG_DRUG
173334-58-2 SECONDARY_CAS_RN
325646 RXNORM
C1120110 UMLSCUI
CHEBI:601027 CHEBI
C41 PDB_CHEM_ID
CHEMBL1639 ChEMBL_ID
CHEMBL3545059 ChEMBL_ID
DB09026 DRUGBANK_ID
C446481 MESH_SUPPLEMENTAL_RECORD_UI
4812 IUPHAR_LIGAND_ID
7992 INN_ID
502FWN4Q32 UNII
5493444 PUBCHEM_CID
108166 MMSL
23512 MMSL
310257 MMSL
34310 MMSL
d06665 MMSL
4025960 VANDF
4030489 VANDF
011991 NDDF
011995 NDDF
425981005 SNOMEDCT_US
426725002 SNOMEDCT_US
427002003 SNOMEDCT_US
502FWN4Q32 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ALISKIREN HUMAN PRESCRIPTION DRUG LABEL 1 49884-424 TABLET, FILM COATED 150 mg ORAL ANDA 28 sections
ALISKIREN HUMAN PRESCRIPTION DRUG LABEL 1 49884-425 TABLET, FILM COATED 300 mg ORAL ANDA 28 sections
Tekturna HUMAN PRESCRIPTION DRUG LABEL 1 54868-5772 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
Tekturna HCT HUMAN PRESCRIPTION DRUG LABEL 2 54868-6041 TABLET, FILM COATED 150 mg ORAL NDA 28 sections
Tekturna HUMAN PRESCRIPTION DRUG LABEL 1 54868-6042 TABLET, FILM COATED 300 mg ORAL NDA 29 sections
Tekturna HCT HUMAN PRESCRIPTION DRUG LABEL 2 54868-6103 TABLET, FILM COATED 300 mg ORAL NDA 28 sections
Tekturna HCT HUMAN PRESCRIPTION DRUG LABEL 2 54868-6194 TABLET, FILM COATED 300 mg ORAL NDA 28 sections
Aliskiren HUMAN PRESCRIPTION DRUG LABEL 1 66993-141 TABLET, FILM COATED 150 mg ORAL NDA authorized generic 28 sections
Aliskiren HUMAN PRESCRIPTION DRUG LABEL 1 66993-142 TABLET, FILM COATED 300 mg ORAL NDA authorized generic 28 sections
Tekturna HCT HUMAN PRESCRIPTION DRUG LABEL 2 70839-112 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
Tekturna HCT HUMAN PRESCRIPTION DRUG LABEL 2 70839-125 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
Tekturna HUMAN PRESCRIPTION DRUG LABEL 1 70839-150 TABLET, FILM COATED 150 mg ORAL NDA 28 sections
Tekturna HUMAN PRESCRIPTION DRUG LABEL 1 70839-300 TABLET, FILM COATED 300 mg ORAL NDA 28 sections
Tekturna HCT HUMAN PRESCRIPTION DRUG LABEL 2 70839-312 TABLET, FILM COATED 300 mg ORAL NDA 29 sections
Tekturna HCT HUMAN PRESCRIPTION DRUG LABEL 2 70839-325 TABLET, FILM COATED 300 mg ORAL NDA 29 sections