FDA.reportPublic FDA data

Varithena

Product NDC
60635-107
11-digit product format
606350107
Labeler code
60635
Product ID
60635-107_2c9274b3-4b99-4d9c-b90a-7f30379eb597
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
polidocanol
Dosage form
KIT
Labeler
Biocompatibles, Inc.
Application
NDA205098
Marketing category
NDA
Marketing start
2017-12-22
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60635-107-012022-12-21C16284748780-19d75b9cf-e98d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013
60635-107-012022-12-21C16284748780-19d75b9cf-e98d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013
60635-107-012022-07-29C16284748780-19d75b9cf-e98d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013
60635-107-012022-07-29C16284748780-19d75b9cf-e98d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013
60635-107-012020-07-22C16284748780-19d75b9cf-e98d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013
60635-107-012020-07-22C16284748780-19d75b9cf-e98d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLIDOCANOLACTIVE INGREDIENT0AWH8BFG9AVARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5
POLIDOCANOLACTIVE MOIETY0AWH8BFG9AVARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MVARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5
CARBON DIOXIDEINACTIVE INGREDIENT142M471B3JVARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5
OXYGENINACTIVE INGREDIENTS88TT14065VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TVARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RVARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60635-107VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]14Legacy NDC20241012_dfd6b4a0-b0dc-11e2-9e96-0800200c9a66.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60635-107-01606350107011 POUCH in 1 CARTON (60635-107-01) > 1 KIT in 1 POUCH * 7.75 mL in 1 CANISTER (60635-007-01) * 303 mL in 1 CANISTER1 pouch2017-12-220000-00-00NoNoCurrent