FDA.reportPublic FDA data

Jynarque

Product NDC
59148-088
11-digit product format
591480088
Labeler code
59148
Product ID
59148-088_3be8a6fe-a8d0-43ca-a84d-183b522a3cf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolvaptan
Dosage form
KIT
Labeler
Otsuka America Pharmaceutical, Inc.
Application
NDA204441
Marketing category
NDA
Marketing start
2018-04-23
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204441-001JYNARQUETOLVAPTAN15MGTABLET / ORALAB2RLD2018-04-23
N204441-002JYNARQUETOLVAPTAN30MGTABLET / ORALAB2RLD2018-04-23
N204441-003JYNARQUETOLVAPTAN45MGTABLET / ORALABRLD, RS2018-04-23
N204441-004JYNARQUETOLVAPTAN60MGTABLET / ORALAB2RLD2018-04-23
N204441-005JYNARQUETOLVAPTAN90MGTABLET / ORALABRLD2018-04-23

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
N204441-001AB2
N204441-002AB2
N204441-003AB
N204441-004AB2
N204441-005AB

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204441-00185017302026-09-01Drug substance2018-05-21
N204441-001109056942030-04-07Drug product2021-02-26
N204441-00285017302026-09-01Drug substance2018-05-21
N204441-002109056942030-04-07Drug product2021-02-26
N204441-00385017302026-09-01Drug substance2018-05-21
N204441-003109056942030-04-07Drug product2021-02-26
N204441-00485017302026-09-01Drug substance2018-05-21
N204441-004109056942030-04-07Drug product2021-02-26
N204441-00585017302026-09-01Drug substance2018-05-21
N204441-005109056942030-04-07Drug product2021-02-26

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JynarqueTOLVAPTANOtsuka America Pharmaceutical, Inc.3febc0a1-9e5a-4ce0-843d-210f21d862c42025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

boxed warning

WARNING: RISK OF SERIOUS LIVER INJURY JYNARQUE (tolvaptan) can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported [see Warnings and Precautions (5.1) ] . Measure ALT, AST and bilirubin before initiating treatment, at 2 weeks and 4 weeks after initiation, then monthly for the first 18 months and every 3 months thereafter [see Warnings and Precautions (5.1) ] . Prompt action in response to laboratory abnormalities, signs, or symptoms indicative of hepatic injury can mitigate, but not eliminate, the risk of serious hepatotoxicity. Because of the risks of serious liver injury, JYNARQUE is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the Tolvaptan for ADPKD Shared System REMS [see Warnings and Precautions (5.2) ] . WARNING: RISK OF SERIOUS LIVER INJURY See full prescribing information for complete boxed warning . JYNARQUE (tolvaptan) can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported ( 5.1 ) Measure transaminases and bilirubin before initiating treatment, at 2 weeks and 4 weeks after initiation, then continuing monthly for the first 18 months and every 3 months thereafter ( 5.1 ) JYNARQUE is available only through a restricted distribution program called the Tolvaptan for ADPKD Shared System REMS ( 5.2 )

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Hypernatremia, dehydration and hypovolemia: May require intervention ( 5.3 ) 5.1 Serious Liver Injury JYNARQUE can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported in the post-marketing ADPKD experience. Discontinuation in response to laboratory abnormalities or signs or symptoms of liver injury (such as fatigue, anorexia, nausea, right upper abdominal discomfort, vomiting, fever, rash, pruritus, icterus, dark urine or jaundice) can reduce the risk of severe hepatotoxicity. In a 3-year placebo-controlled trial and its open-label extension (in which patients' liver tests were monitored every 4 months), evidence of serious hepatocellular injury (elevations of hepatic transaminases of at least 3 times the upper limit of normal [ULN] combined with elevated bilirubin at least 2 times the ULN) occurred in 0.2% (3/1487) of tolvaptan-treated patients compared to none of the placebo-treated patients. To reduce the risk of significant or irreversible liver injury, assess ALT, AST and bilirubin prior to initiation of JYNARQUE, at 2 weeks and 4 weeks after initiation, then monthly for 18 months and every 3 months thereafter. At the onset of signs or symptoms consistent with hepatic injury or if ALT, AST, or bilirubin increase to >2 times ULN, immediately discontinue JYNARQUE, obtain repeat tests as soon as possible (within 48 to 72 hours), and continue testing as appropriate. If laboratory abnormalities stabilize or resolve, JYNARQUE may be reinitiated with increased frequency of monitoring as long as ALT and AST remain below 3 times the ULN. Do not restart JYNARQUE in patients who experience signs or symptoms consistent with hepatic injury or whose ALT or AST ever exceeds 3 times the ULN during treatment with tolvaptan, unless there is another explanation for liver injury and the injury has resolved. In patients with a stable, low baseline AST or ALT, an increase above 2 times baseline, even if less than 2 times the ULN, may indicate early liver injury. Such elevations may warrant treatment suspension and prompt (48 to 72 hours) re-evaluation of liver test trends prior to reinitiating therapy with more frequent monitoring. 5.2 Tolvaptan for ADPKD Shared System REMS JYNARQUE is available only through a restricted distribution program under a Risk Evaluation and Mitigatio...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Serious Liver Injury [see Boxed Warning and Warnings and Precautions (5.1) ] Hypernatremia, Dehydration and Hypovolemia [see Warnings and Precautions (5.3) ] Drug Interactions with Inhibitors of CYP3A [see Warnings and Precautions (5.4) ] Most common observed adverse reactions with JYNARQUE (incidence >10% and at least twice that for placebo) were thirst, polyuria, nocturia, pollakiuria and polydipsia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. JYNARQUE has been studied in over 3000 patients with ADPKD. Long-term, placebo-controlled safety information of JYNARQUE in ADPKD is principally derived from two trials where 1,413 subjects received tolvaptan and 1,098 received placebo for at least 12 months across both studies. TEMPO 3:4: A Phase 3, Double-Blind, Placebo-Controlled, Randomized Trial in Early, Rapidly-Progressing ADPKD The TEMPO 3:4 (NCT00428948) trial employed a two-arm, 2:1 randomization to tolvaptan or placebo, titrated to a maximally-tolerated total daily dose of 60 to 120 mg. A total of 961 subjects with rapidly progressing ADPKD were randomized to JYNARQUE. Of these, 742 (77%) subjects who were treated with JYNARQUE remained on treatment for at least 3 years. The average daily dose in these subjects was 96 mg daily. Adverse events that led to discontinuation were reported for 15.4% (148/961) of subjects in the JYNARQUE group and 5.0% (24/483) of subjects in the placebo group. Aquaretic effects were the most common reasons for discontinuation of JYNARQUE. These included pollakiuria, polyuria, or nocturia in 63 (6.6%) subjects treated with JYNARQUE compared to 1 subject (0.2%) treated with placebo. Table 2 lists the adverse reactions that occurred in at least 3% of ADPKD subjects treated with JYNARQUE and at least 1.5% more than on placebo. Table 2: TEMPO 3:4, Treatment Emergent Adverse Reactions in ≥3% of JYNARQUE Treated Subj...

adverse reactions table

Table 2: TEMPO 3:4, Treatment Emergent Adverse Reactions in ≥3% of JYNARQUE Treated Subjects with Risk Difference ≥1.5%, Randomized PeriodAdverse ReactionTolvaptan (N=961)Placebo (N=483)Number of SubjectsProportion (%)100× (Number of subjects with an adverse event/N)Annualized Rate100× (Number of subjects with an adverse event/Total subject years of drug exposure)Number of SubjectsProportion (%)Annualized RateIncreased urinationIncreased urination includes micturition urgency, nocturia, pollakiuria, polyuria66869.528.613528.010.3ThirstThirst includes polydipsia and thirst61263.726.211323.48.7Dry mouth15416.06.66012.44.6Fatigue13113.65.6479.73.6Diarrhea12813.35.55311.04.1Dizziness10911.34.7428.73.2Dyspepsia767.93.3163.31.2Decreased appetite697.23.051.00.4Abdominal distension474.92.0163.31.2Dry skin474.92.081.70.6Rash404.21.791.90.7Hyperuricemia373.91.691.90.7Palpitations343.51.561.20.5

Additional Listing Data#

Finished product
Yes
Brand name base
Jynarque
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Unii21G72T1950
Rxcui2044355, 2044357, 2044359, 2044361, 2044363, 2044365, 2044367, 2044369, 2044966, 2044967, 2044968, 2044969, 2044970, 2044971, 2274813, 2274814, 2274815, 2274816, 2719335, 2719337

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7f9e53d9-c2b2-4ac0-9989-193b7a2ecee6Product name220250805
48801b9b-adbb-003d-f253-aa66331fded9Product name520240730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59148-088-07Jynarque1 in 1 BLISTER PACKKIT119
59148-088-28Jynarque4 in 1 CARTONKIT419

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59148-088-07EA - Each59148-088e11ec379-cef5-400b-845a-483c4fa6225612018-05-09
59148-088-28EA - Each59148-0881f73513e-78bc-4cda-8c40-2e0ad393296a12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59148-088JYNARQUE (TOLVAPTAN) KIT JYNARQUE (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]18Current NDC, Legacy NDC, 2 package rows20250508_3febc0a1-9e5a-4ce0-843d-210f21d862c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2274814{28 (tolvaptan 15 MG Oral Tablet [Jynarque]) / 28 (tolvaptan 30 MG Oral Tablet [Jynarque]) } Pack [Jynarque 30/15 Carton]BPCK3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044969{28 (tolvaptan 15 MG Oral Tablet [Jynarque]) / 28 (tolvaptan 45 MG Oral Tablet [Jynarque]) } Pack [Jynarque 45/15 Carton]BPCK3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044967{28 (tolvaptan 30 MG Oral Tablet [Jynarque]) / 28 (tolvaptan 60 MG Oral Tablet [Jynarque]) } Pack [Jynarque 60/30 Carton]BPCK3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044971{28 (tolvaptan 30 MG Oral Tablet [Jynarque]) / 28 (tolvaptan 90 MG Oral Tablet [Jynarque]) } Pack [Jynarque 90/30 Carton]BPCK3febc0a1-9e5a-4ce0-843d-210f21d862c419
2274816{56 (tolvaptan 15 MG Oral Tablet [Jynarque]) } Pack [Jynarque 15/15 Carton]BPCK3febc0a1-9e5a-4ce0-843d-210f21d862c419
2274813{28 (tolvaptan 15 MG Oral Tablet) / 28 (tolvaptan 30 MG Oral Tablet) } PackGPCK3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044968{28 (tolvaptan 15 MG Oral Tablet) / 28 (tolvaptan 45 MG Oral Tablet) } PackGPCK3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044966{28 (tolvaptan 30 MG Oral Tablet) / 28 (tolvaptan 60 MG Oral Tablet) } PackGPCK3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044970{28 (tolvaptan 30 MG Oral Tablet) / 28 (tolvaptan 90 MG Oral Tablet) } PackGPCK3febc0a1-9e5a-4ce0-843d-210f21d862c419
2274815{56 (tolvaptan 15 MG Oral Tablet) } PackGPCK3febc0a1-9e5a-4ce0-843d-210f21d862c419
2274816JYNARQUE 15 MG / 15 MG Carton PackPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044355JYNARQUE 15 MG Oral TabletPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2274814JYNARQUE 30 MG / 15 MG Carton PackPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044357JYNARQUE 30 MG Oral TabletPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044969JYNARQUE 45 MG / 15 MG Carton PackPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044361JYNARQUE 45 MG Oral TabletPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044967JYNARQUE 60 MG / 30 MG Carton PackPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044365JYNARQUE 60 MG Oral TabletPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044971JYNARQUE 90 MG / 30 MG Carton PackPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044369JYNARQUE 90 MG Oral TabletPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2274815tolvaptan 15 MG / 15 MG Carton PackPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2719335tolvaptan 15 MG Oral TabletPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2274813tolvaptan 30 MG / 15 MG Carton PackPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2719337tolvaptan 30 MG Oral TabletPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044968tolvaptan 45 MG / 15 MG Carton PackPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044359tolvaptan 45 MG Oral TabletPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044966tolvaptan 60 MG / 30 MG Carton PackPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044363tolvaptan 60 MG Oral TabletPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044970tolvaptan 90 MG / 30 MG Carton PackPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044367tolvaptan 90 MG Oral TabletPSN3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044355tolvaptan 15 MG Oral Tablet [Jynarque]SBD3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044357tolvaptan 30 MG Oral Tablet [Jynarque]SBD3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044361tolvaptan 45 MG Oral Tablet [Jynarque]SBD3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044365tolvaptan 60 MG Oral Tablet [Jynarque]SBD3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044369tolvaptan 90 MG Oral Tablet [Jynarque]SBD3febc0a1-9e5a-4ce0-843d-210f21d862c419
2719335tolvaptan 15 MG Oral TabletSCD3febc0a1-9e5a-4ce0-843d-210f21d862c419
2719337tolvaptan 30 MG Oral TabletSCD3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044359tolvaptan 45 MG Oral TabletSCD3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044363tolvaptan 60 MG Oral TabletSCD3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044367tolvaptan 90 MG Oral TabletSCD3febc0a1-9e5a-4ce0-843d-210f21d862c419
22748164 {14 (tolvaptan 15 MG Oral Tablet [Jynarque]) } Pack [Jynarque 15/15 Carton]SY3febc0a1-9e5a-4ce0-843d-210f21d862c419
22748154 {14 (tolvaptan 15 MG Oral Tablet) } Carton PackSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
22748144 {7 (tolvaptan 30 MG Oral Tablet [Jynarque]) / 7 (tolvaptan 15 MG Oral Tablet [Jynarque]) } Pack [Jynarque 45/15 Carton]SY3febc0a1-9e5a-4ce0-843d-210f21d862c419
22748134 {7 (tolvaptan 30 MG Oral Tablet) / 7 (tolvaptan 15 MG Oral Tablet) } Carton PackSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
20449694 {7 (tolvaptan 45 MG Oral Tablet [Jynarque]) / 7 (tolvaptan 15 MG Oral Tablet [Jynarque]) } Pack [Jynarque 45/15 Carton]SY3febc0a1-9e5a-4ce0-843d-210f21d862c419
20449684 {7 (tolvaptan 45 MG Oral Tablet) / 7 (tolvaptan 15 MG Oral Tablet) } Carton PackSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
20449674 {7 (tolvaptan 60 MG Oral Tablet [Jynarque]) / 7 (tolvaptan 30 MG Oral Tablet [Jynarque]) } Pack [Jynarque 60/30 Carton]SY3febc0a1-9e5a-4ce0-843d-210f21d862c419
20449664 {7 (tolvaptan 60 MG Oral Tablet) / 7 (tolvaptan 30 MG Oral Tablet) } Carton PackSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
20449714 {7 (tolvaptan 90 MG Oral Tablet [Jynarque]) / 7 (tolvaptan 30 MG Oral Tablet [Jynarque]) } Pack [Jynarque 90/30 Carton]SY3febc0a1-9e5a-4ce0-843d-210f21d862c419
20449704 {7 (tolvaptan 90 MG Oral Tablet) / 7 (tolvaptan 30 MG Oral Tablet) } Carton PackSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2274816Jynarque 15 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Capsules EachSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044355Jynarque 15 MG Oral TabletSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2274814Jynarque 30 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Capsules EachSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044357Jynarque 30 MG Oral TabletSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044969Jynarque 45 MG / 15 MG Carton PackSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044969Jynarque 45 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Capsules EachSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044361Jynarque 45 MG Oral TabletSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044967Jynarque 60 MG / 30 MG Carton PackSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044967Jynarque 60 MG / 30 MG Carton Pack, 4 Blister Cards, 14 Capsules EachSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044365Jynarque 60 MG Oral TabletSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044971Jynarque 90 MG / 30 MG Carton PackSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044971Jynarque 90 MG / 30 MG Carton Pack, 4 Blister Cards, 14 Capsules EachSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044369Jynarque 90 MG Oral TabletSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2274815tolvaptan 15 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Tablets EachSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2274813tolvaptan 30 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Tablets EachSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044968tolvaptan 45 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Tablets EachSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044966tolvaptan 60 MG / 30 MG Carton Pack, 4 Blister Cards, 14 Tablets EachSY3febc0a1-9e5a-4ce0-843d-210f21d862c419
2044970tolvaptan 90 MG / 30 MG Carton Pack, 4 Blister Cards, 14 Tablets EachSY3febc0a1-9e5a-4ce0-843d-210f21d862c419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59148-088-07591480088071 in 1 BLISTER PACKHistorical
59148-088-28591480088284 BLISTER PACK in 1 CARTON (59148-088-28) / 1 KIT in 1 BLISTER PACK (59148-088-07) 4 blister pack2018-04-230000-00-00NoNoCurrent