Tolvaptan
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . for oral use Initial U.S. Approval: 2009
Approved
Approval ID
5b14ba2b-9f80-41d6-9613-f16d3cf37d25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 10, 2022
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tolvaptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-770
Application NumberANDA206119
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tolvaptan
Product Specifications
Route of AdministrationORAL
Effective DateMarch 10, 2022
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TOLVAPTANActive
Quantity: 30 mg in 1 1
Code: 21G72T1950
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Tolvaptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-768
Application NumberANDA206119
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tolvaptan
Product Specifications
Route of AdministrationORAL
Effective DateMarch 10, 2022
FDA Product Classification
INGREDIENTS (8)
TOLVAPTANActive
Quantity: 15 mg in 1 1
Code: 21G72T1950
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT