FDA.reportPublic FDA data

Tolvaptan

Product NDC
49884-768
11-digit product format
498840768
Labeler code
49884
Product ID
49884-768_73a11064-c070-4323-bb7a-59dd36dc1eee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolvaptan
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA206119
Marketing category
ANDA
Marketing start
2022-03-10
Substance
TOLVAPTAN
Active strength
15 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
TOLVAPTAN15 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
49884-768-52Tolvaptan10 in 1 BLISTER PACKTABLET108
49884-768-54Tolvaptan1 in 1 CARTONTABLET18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-768-52EA - Each49884-768e61d44dc-2bba-49d9-9c84-839c09d25f3812022-04-06
49884-768-54EA - Each49884-768754eda60-e556-490b-bc61-af7a2a6df15112022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-768TOLVAPTAN TABLET [ENDO USA, INC.]8Current NDC, Legacy NDC, 2 package rows20240926_5b14ba2b-9f80-41d6-9613-f16d3cf37d25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849827tolvaptan 15 MG Hyponatremia Oral TabletPSN5b14ba2b-9f80-41d6-9613-f16d3cf37d258
849833tolvaptan 30 MG Hyponatremia Oral TabletPSN5b14ba2b-9f80-41d6-9613-f16d3cf37d258
849827Hyponatremia tolvaptan 15 MG Oral TabletSCD5b14ba2b-9f80-41d6-9613-f16d3cf37d258
849833Hyponatremia tolvaptan 30 MG Oral TabletSCD5b14ba2b-9f80-41d6-9613-f16d3cf37d258
849827tolvaptan 15 MG Hyponatremia Oral TabletSY5b14ba2b-9f80-41d6-9613-f16d3cf37d258
849833tolvaptan 30 MG Hyponatremia Oral TabletSY5b14ba2b-9f80-41d6-9613-f16d3cf37d258

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-768-524988407685210 in 1 BLISTER PACKHistorical
49884-768-54498840768541 BLISTER PACK in 1 CARTON (49884-768-54) / 10 TABLET in 1 BLISTER PACK (49884-768-52) 1 blister pack2022-03-100000-00-00NoNoCurrent