Varithena

Product NDC
60635-123
11-digit product format
606350123
Labeler code
60635
Product ID
60635-123_636003c5-8a21-4380-909c-36f00c05fd88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
polidocanol
Dosage form
KIT
Labeler
Biocompatibles, Inc.
Application
NDA205098
Marketing category
NDA
Marketing start
2014-07-10
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60635-123DDiscontinued by firm2026-11-02
excluded packagepackage60635-12360635-123-01DDiscontinued by firm2026-11-02

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60635-123-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60635-123-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60635-123-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60635-123-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60635-123-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60635-123-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60635-123-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60635-123-01DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60635-123-01DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60635-123-01DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60635-123-01DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60635-123-01DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage60635-123-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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.

Product history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-25c2088c7a36db…
2026-10-15 13:18:302026-09N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-21c2088c7a36db…
2026-09-14 22:38:342026-08N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-2584e616aacf4f…
2026-09-14 22:38:342026-08N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-2184e616aacf4f…
2026-08-18 06:07:402026-07N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-25caaa826d4ba7…
2026-08-18 06:07:402026-07N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2017-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205098-001VARITHENA180MG/18ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2013-11-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N205098-002VARITHENA77.5MG/7.75ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2017-12-214b0b4de00fa7…

Observed Orange Book patent history#

Patent history page 1 of 6 · 230 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N205098-00178149432027-11-19U-1461Drug productc2088c7a36db…
2026-10-15 13:18:302026-09N205098-00194806522032-05-12Drug product2016-11-30c2088c7a36db…
2026-09-14 22:38:342026-08N205098-00178149432027-11-19U-1461Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N205098-00194806522032-05-12Drug product2016-11-3084e616aacf4f…
2026-08-18 06:07:402026-07N205098-00178149432027-11-19U-1461Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N205098-00194806522032-05-12Drug product2016-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205098-00178149432027-11-19U-1461Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205098-00194806522032-05-12Drug product2016-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205098-00178149432027-11-19U-1461Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205098-00194806522032-05-12Drug product2016-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N205098-00178149432027-11-19U-1461Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205098-00194806522032-05-12Drug product2016-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205098-00178149432027-11-19U-1461Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205098-00194806522032-05-12Drug product2016-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205098-00178149432027-11-19U-1461Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205098-00194806522032-05-12Drug product2016-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205098-00181229172024-09-09Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205098-00177319862024-11-17U-1463Drug substance, Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205098-00178149432027-11-19U-1461Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205098-00194806522032-05-12Drug product2016-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205098-00181229172024-09-09Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205098-00177319862024-11-17U-1463Drug substance, Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205098-00178149432027-11-19U-1461Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205098-00194806522032-05-12Drug product2016-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205098-00181229172024-09-09Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205098-00177319862024-11-17U-1463Drug substance, Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205098-00178149432027-11-19U-1461Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205098-00194806522032-05-12Drug product2016-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205098-00181229172024-09-09Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205098-00177319862024-11-17U-1463Drug substance, Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205098-00178149432027-11-19U-1461Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205098-00194806522032-05-12Drug product2016-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205098-00181229172024-09-09Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N205098-00177319862024-11-17U-1463Drug substance, Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N205098-00178149432027-11-19U-1461Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N205098-00194806522032-05-12Drug product2016-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205098-00181229172024-09-09Drug product79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205098-00177319862024-11-17U-1463Drug substance, Drug product79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205098-00178149432027-11-19U-1461Drug product79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205098-00194806522032-05-12Drug product2016-11-3079d66fd596c7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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#

Effective, Related label table
EffectiveRelated label
2020-07-22These 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
2020-07-22These 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
2020-07-22These 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
2020-07-22These 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
2020-07-22These 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
2020-03-12These 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
2020-03-12These 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
2020-03-12These 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
2020-03-12These 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
2020-03-12These 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
2020-01-31These 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
2020-01-31These 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
2020-01-31These 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
2020-01-31These 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
2020-01-31These 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
60635-123-01Varithena1 in 1 BOXKIT117
60635-123-01Varithena1 in 1 BLISTER PACKKIT117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60635-123-01EA - Each60635-12338b7cc09-0f1f-4112-87fa-68a886d08f3212016-07-19

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
60635-123VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]14Legacy 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 formatDescriptionUnitsStatus
60635-018-016063500180118 mL in 1 CANISTER18 mlHistorical
60635-123-01606350123011 in 1 BOXHistorical