FDA.reportPublic FDA data

tolvaptan

Product NDC
60505-4318
11-digit product format
605054318
Labeler code
60505
Product ID
60505-4318_690cc374-8439-3e20-77d1-acade3cad332
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolvaptan
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA207605
Marketing category
ANDA
Marketing start
2022-07-05
Substance
TOLVAPTAN
Active strength
30 mg/1
Pharmacologic classes
Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA]
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLVAPTAN30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii21G72T1950
Rxcui849827, 849833

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
60505-4318-0tolvaptan1 in 1 CARTONTABLET18
60505-4318-0tolvaptan10 in 1 BLISTER PACKTABLET108
60505-4318-3tolvaptan30 in 1 BOTTLETABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4318-0EA - Each60505-43188a510075-fc0b-472d-9413-38cfb46fc9e812022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4318TOLVAPTAN TABLET [APOTEX CORP.]7Current NDC, Legacy NDC, 3 package rows20241003_d9fd11d0-4269-12fb-95cf-b3c11d75e479.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849827tolvaptan 15 MG Hyponatremia Oral TabletPSNd9fd11d0-4269-12fb-95cf-b3c11d75e4798
849833tolvaptan 30 MG Hyponatremia Oral TabletPSNd9fd11d0-4269-12fb-95cf-b3c11d75e4798
849827Hyponatremia tolvaptan 15 MG Oral TabletSCDd9fd11d0-4269-12fb-95cf-b3c11d75e4798
849833Hyponatremia tolvaptan 30 MG Oral TabletSCDd9fd11d0-4269-12fb-95cf-b3c11d75e4798
849827tolvaptan 15 MG Hyponatremia Oral TabletSYd9fd11d0-4269-12fb-95cf-b3c11d75e4798
849833tolvaptan 30 MG Hyponatremia Oral TabletSYd9fd11d0-4269-12fb-95cf-b3c11d75e4798

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-4318-0605054318001 BLISTER PACK in 1 CARTON (60505-4318-0) / 10 TABLET in 1 BLISTER PACK1 blister pack2022-07-050000-00-00NoNoCurrent
60505-4318-36050543180330 TABLET in 1 BOTTLE (60505-4318-3) 30 tablet2022-07-010000-00-00NoNoCurrent