FDA.reportPublic FDA data

TOLVAPTAN

Product NDC
70748-244
11-digit product format
707480244
Labeler code
70748
Product ID
70748-244_3e110564-6fd2-4450-a3d2-a5de70b85f2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOLVAPTAN
Dosage form
KIT
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA216063
Marketing category
ANDA
Marketing start
2025-05-12
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii21G72T1950
Rxcui2044359, 2044363, 2044367, 2044966, 2044968, 2044970, 2274813, 2274815, 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
70748-244-11TOLVAPTAN1 in 1 BLISTER PACKKIT16
70748-244-13TOLVAPTAN4 in 1 CARTONKIT46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70748-244TOLVAPTAN ( TOLVAPTAN ) KIT TOLVAPTAN TABLET [LUPIN PHARMACEUTICALS, INC.]6Current NDC, 2 package rows20250513_9ba38e23-ca66-4406-92af-bbb8fad00e16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2274813{28 (tolvaptan 15 MG Oral Tablet) / 28 (tolvaptan 30 MG Oral Tablet) } PackGPCK9ba38e23-ca66-4406-92af-bbb8fad00e166
2044968{28 (tolvaptan 15 MG Oral Tablet) / 28 (tolvaptan 45 MG Oral Tablet) } PackGPCK9ba38e23-ca66-4406-92af-bbb8fad00e166
2044966{28 (tolvaptan 30 MG Oral Tablet) / 28 (tolvaptan 60 MG Oral Tablet) } PackGPCK9ba38e23-ca66-4406-92af-bbb8fad00e166
2044970{28 (tolvaptan 30 MG Oral Tablet) / 28 (tolvaptan 90 MG Oral Tablet) } PackGPCK9ba38e23-ca66-4406-92af-bbb8fad00e166
2274815{56 (tolvaptan 15 MG Oral Tablet) } PackGPCK9ba38e23-ca66-4406-92af-bbb8fad00e166
2274815tolvaptan 15 MG / 15 MG Carton PackPSN9ba38e23-ca66-4406-92af-bbb8fad00e166
2719335tolvaptan 15 MG Oral TabletPSN9ba38e23-ca66-4406-92af-bbb8fad00e166
2274813tolvaptan 30 MG / 15 MG Carton PackPSN9ba38e23-ca66-4406-92af-bbb8fad00e166
2719337tolvaptan 30 MG Oral TabletPSN9ba38e23-ca66-4406-92af-bbb8fad00e166
2044968tolvaptan 45 MG / 15 MG Carton PackPSN9ba38e23-ca66-4406-92af-bbb8fad00e166
2044359tolvaptan 45 MG Oral TabletPSN9ba38e23-ca66-4406-92af-bbb8fad00e166
2044966tolvaptan 60 MG / 30 MG Carton PackPSN9ba38e23-ca66-4406-92af-bbb8fad00e166
2044363tolvaptan 60 MG Oral TabletPSN9ba38e23-ca66-4406-92af-bbb8fad00e166
2044970tolvaptan 90 MG / 30 MG Carton PackPSN9ba38e23-ca66-4406-92af-bbb8fad00e166
2044367tolvaptan 90 MG Oral TabletPSN9ba38e23-ca66-4406-92af-bbb8fad00e166
2719335tolvaptan 15 MG Oral TabletSCD9ba38e23-ca66-4406-92af-bbb8fad00e166
2719337tolvaptan 30 MG Oral TabletSCD9ba38e23-ca66-4406-92af-bbb8fad00e166
2044359tolvaptan 45 MG Oral TabletSCD9ba38e23-ca66-4406-92af-bbb8fad00e166
2044363tolvaptan 60 MG Oral TabletSCD9ba38e23-ca66-4406-92af-bbb8fad00e166
2044367tolvaptan 90 MG Oral TabletSCD9ba38e23-ca66-4406-92af-bbb8fad00e166
22748154 {14 (tolvaptan 15 MG Oral Tablet) } Carton PackSY9ba38e23-ca66-4406-92af-bbb8fad00e166
22748134 {7 (tolvaptan 30 MG Oral Tablet) / 7 (tolvaptan 15 MG Oral Tablet) } Carton PackSY9ba38e23-ca66-4406-92af-bbb8fad00e166
20449684 {7 (tolvaptan 45 MG Oral Tablet) / 7 (tolvaptan 15 MG Oral Tablet) } Carton PackSY9ba38e23-ca66-4406-92af-bbb8fad00e166
20449664 {7 (tolvaptan 60 MG Oral Tablet) / 7 (tolvaptan 30 MG Oral Tablet) } Carton PackSY9ba38e23-ca66-4406-92af-bbb8fad00e166
20449704 {7 (tolvaptan 90 MG Oral Tablet) / 7 (tolvaptan 30 MG Oral Tablet) } Carton PackSY9ba38e23-ca66-4406-92af-bbb8fad00e166
2274815tolvaptan 15 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Tablets EachSY9ba38e23-ca66-4406-92af-bbb8fad00e166
2274813tolvaptan 30 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Tablets EachSY9ba38e23-ca66-4406-92af-bbb8fad00e166
2044968tolvaptan 45 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Tablets EachSY9ba38e23-ca66-4406-92af-bbb8fad00e166
2044966tolvaptan 60 MG / 30 MG Carton Pack, 4 Blister Cards, 14 Tablets EachSY9ba38e23-ca66-4406-92af-bbb8fad00e166
2044970tolvaptan 90 MG / 30 MG Carton Pack, 4 Blister Cards, 14 Tablets EachSY9ba38e23-ca66-4406-92af-bbb8fad00e166

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70748-244-11707480244111 in 1 BLISTER PACKHistorical
70748-244-13707480244134 BLISTER PACK in 1 CARTON (70748-244-13) / 1 KIT in 1 BLISTER PACK (70748-244-11) 4 blister pack2025-05-12NoNoCurrent