Home NDC 60635-118 Varithena
Product NDC 60635-118
11-digit product format 606350118
Labeler code 60635
Product ID 60635-118_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 2014-07-10
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205098-001 VARITHENA POLIDOCANOL 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 N205098-002 VARITHENA POLIDOCANOL 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205098-001 7814943 2027-11-19 U-1461 Drug product N205098-001 9480652 2032-05-12 Drug product 2016-11-30
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N205098-001 7814943 2027-11-19 U-1461 Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base Varithena
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1485068 Internal RxNorm lookup 1485070 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 60635-118-01 2022-12-21 C162847 48780-1 9d75b9cf-e98d-f424-e053-dadaa90a57ce These 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 60635-118-01 2022-12-21 C162847 48780-1 9d75b9cf-e98d-f424-e053-dadaa90a57ce These 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 60635-118-01 2022-07-29 C162847 48780-1 9d75b9cf-e98d-f424-e053-dadaa90a57ce These 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 60635-118-01 2022-07-29 C162847 48780-1 9d75b9cf-e98d-f424-e053-dadaa90a57ce These 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 60635-118-01 2020-07-22 C162847 48780-1 9d75b9cf-e98d-f424-e053-dadaa90a57ce These 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 60635-118-01 2020-07-22 C162847 48780-1 9d75b9cf-e98d-f424-e053-dadaa90a57ce These 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 60635-118-01 2020-03-12 C162847 48780-1 9d75b9cf-e98d-f424-e053-dadaa90a57ce These 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 60635-118-01 2020-03-12 C162847 48780-1 9d75b9cf-e98d-f424-e053-dadaa90a57ce These 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 60635-118-01 2020-01-31 C162847 48780-1 9d75b9cf-e98d-f424-e053-dadaa90a57ce These 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 60635-118-01 2020-01-31 C162847 48780-1 9d75b9cf-e98d-f424-e053-dadaa90a57ce These 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 NDC Product Description Form Quantity Strength SPL version 60635-018-01 Varithena 18 mL in 1 CANISTER INJECTABLE FOAM 18 mL 10 mg in 1mL 17 60635-118-01 Varithena 1 in 1 POUCH KIT 1 17 60635-118-01 Varithena 1 in 1 CARTON KIT 1 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POLIDOCANOL ACTIVE INGREDIENT 0AWH8BFG9A VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5 POLIDOCANOL ACTIVE MOIETY 0AWH8BFG9A VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5 ALCOHOL INACTIVE INGREDIENT 3K9958V90M VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5 CARBON DIOXIDE INACTIVE INGREDIENT 142M471B3J VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5 OXYGEN INACTIVE INGREDIENT S88TT14065 VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5 POTASSIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 4J9FJ0HL51 VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5 SODIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT 94255I6E2T VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60635-118 VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 14 Current NDC, Legacy NDC, 3 package rows 20241012_dfd6b4a0-b0dc-11e2-9e96-0800200c9a66.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60635-018-01 60635001801 18 mL in 1 CANISTER 18 ml Historical 60635-118-01 60635011801 1 POUCH in 1 CARTON (60635-118-01) / 1 KIT in 1 POUCH * 18 mL in 1 CANISTER (60635-018-01) * 303 mL in 1 CANISTER 1 pouch 2016-06-22 0000-00-00 No No Current