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

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