TOLVAPTAN

Product NDC
60505-4704
11-digit product format
605054704
Labeler code
60505
Product ID
60505-4704_1bcbe7de-c01b-4ace-b2cf-8d663b3f92ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolvaptan
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
NDA022275
Marketing category
NDA
Marketing start
2020-10-15
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-4704-0605054704001 BLISTER PACK in 1 CARTON (60505-4704-0) > 10 TABLET in 1 BLISTER PACK1 blister pack2020-10-150000-00-00NoNoCurrent