FDA.reportPublic FDA data

Varithena

Product NDC
60635-111
11-digit product format
606350111
Labeler code
60635
Product ID
60635-111_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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205098-001VARITHENAPOLIDOCANOL180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-25
N205098-002VARITHENAPOLIDOCANOL77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-21

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205098-00178149432027-11-19U-1461Drug product
N205098-00194806522032-05-12Drug product2016-11-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-25a50c72e98297…
2026-08-01 22:54:322026-06N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-21a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N205098-00178149432027-11-19U-1461Drug producta50c72e98297…
2026-08-01 22:54:322026-06N205098-00194806522032-05-12Drug product2016-11-30a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VarithenaPOLIDOCANOLBoston Scientific Corporationdfd6b4a0-b0dc-11e2-9e96-0800200c9a662026-05-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 205098
application number: NDA205098

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
60635-111-012022-12-21C16284748780-19d75b9cf-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
60635-111-012022-12-21C16284748780-19d75b9cf-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
60635-111-012022-07-29C16284748780-19d75b9cf-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
60635-111-012022-07-29C16284748780-19d75b9cf-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
60635-111-012020-07-22C16284748780-19d75b9cf-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
60635-111-012020-07-22C16284748780-19d75b9cf-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
60635-111VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]14Legacy NDC20241012_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
60635-111-01606350111011 CARTON in 1 PACKAGE (60635-111-01) > 1 POUCH in 1 CARTON > 1 KIT in 1 POUCH * 7.75 mL in 1 CANISTER (60635-007-01) * 303 mL in 1 CANISTER1 carton2017-12-220000-00-00NoNoCurrent