FDA.reportPublic FDA data

Varithena

Product NDC
60635-133
11-digit product format
606350133
Labeler code
60635
Product ID
60635-133_5455a54e-bbb4-4c02-ab6e-e9815136548e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
polidocanol
Dosage form
KIT
Labeler
Boston Scientific Corporation
Application
NDA205098
Marketing category
NDA
Marketing start
2013-11-25
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Varithena
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1485068, 1485070

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
2d2ef081-4f0c-4669-81e8-32b263669a0aProduct name120230801
af534dc0-c9e5-19a6-693c-e7ad53714660Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60635-133-012022-12-21C16284748780-19d75b9cf-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
60635-133-012022-12-21C16284748780-19d75b9cf-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
60635-133-012022-07-29C16284748780-19d75b9cf-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
60635-133-012022-07-29C16284748780-19d75b9cf-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
60635-133-012020-07-22C16284748780-19d75b9cf-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
60635-133-012020-07-22C16284748780-19d75b9cf-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
60635-133-012020-03-12C16284748780-19d75b9cf-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
60635-133-012020-03-12C16284748780-19d75b9cf-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
60635-133-012020-01-31C16284748780-19d75b9cf-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
60635-133-012020-01-31C16284748780-19d75b9cf-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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60635-018-01Varithena18 mL in 1 CANISTERINJECTABLE FOAM18 mL10 mg in 1mL17
60635-133-01Varithena1 in 1 CARTONKIT117
60635-133-01Varithena1 in 1 PACKAGEKIT117

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
60635-133VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]14Current NDC, Legacy NDC, 3 package rows20241012_dfd6b4a0-b0dc-11e2-9e96-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1485068polidocanol 180 MG in 18 ML Injectable FoamPSNdfd6b4a0-b0dc-11e2-9e96-0800200c9a6617
1485070Varithena 180 MG in 18 ML Injectable FoamPSNdfd6b4a0-b0dc-11e2-9e96-0800200c9a6617
1485070polidocanol 10 MG/ML Injectable Foam [Varithena]SBDdfd6b4a0-b0dc-11e2-9e96-0800200c9a6617
1485068polidocanol 10 MG/ML Injectable FoamSCDdfd6b4a0-b0dc-11e2-9e96-0800200c9a6617
1485068polidocanol 1 % Injectable FoamSYdfd6b4a0-b0dc-11e2-9e96-0800200c9a6617
1485068polidocanol 180 MG per 18 ML Injectable FoamSYdfd6b4a0-b0dc-11e2-9e96-0800200c9a6617
1485070Varithena 1 % Injectable FoamSYdfd6b4a0-b0dc-11e2-9e96-0800200c9a6617
1485070Varithena 10 MG/ML Injectable FoamSYdfd6b4a0-b0dc-11e2-9e96-0800200c9a6617
1485070Varithena 180 MG per 18 ML Intravenous FoamSYdfd6b4a0-b0dc-11e2-9e96-0800200c9a6617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60635-018-016063500180118 mL in 1 CANISTER18 mlHistorical
60635-133-01606350133011 CARTON in 1 PACKAGE (60635-133-01) / 1 POUCH in 1 CARTON / 1 KIT in 1 POUCH * 18 mL in 1 CANISTER (60635-018-01) * 303 mL in 1 CANISTER1 carton2016-06-220000-00-00NoNoCurrent