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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60635-123		D	Discontinued by firm		2026-07-31
excluded package	package	60635-123	60635-123-01	D	Discontinued by firm		2026-07-31

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Varithena	POLIDOCANOL	Boston Scientific Corporation	dfd6b4a0-b0dc-11e2-9e96-0800200c9a66	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205098 application number: NDA205098 ndc (product): 60635-123

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
2d2ef081-4f0c-4669-81e8-32b263669a0a	Product name	1	20230801
af534dc0-c9e5-19a6-693c-e7ad53714660	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60635-123-01	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
60635-123-01	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
60635-123-01	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
60635-123-01	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
60635-123-01	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
60635-123-01	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
60635-123-01	Varithena	1 in 1 BOX	KIT	1		17
60635-123-01	Varithena	1 in 1 BLISTER PACK	KIT	1		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60635-123-01	EA - Each	60635-123	38b7cc09-0f1f-4112-87fa-68a886d08f32	1	2016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
60635-123	VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]	14	Legacy NDC, 3 package rows	20241012_dfd6b4a0-b0dc-11e2-9e96-0800200c9a66.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0AWH8BFG9A	POLIDOCANOL	9002-92-0	polidocanol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1485068	polidocanol 180 MG in 18 ML Injectable Foam	PSN	dfd6b4a0-b0dc-11e2-9e96-0800200c9a66	17
1485070	Varithena 180 MG in 18 ML Injectable Foam	PSN	dfd6b4a0-b0dc-11e2-9e96-0800200c9a66	17
1485070	polidocanol 10 MG/ML Injectable Foam [Varithena]	SBD	dfd6b4a0-b0dc-11e2-9e96-0800200c9a66	17
1485068	polidocanol 10 MG/ML Injectable Foam	SCD	dfd6b4a0-b0dc-11e2-9e96-0800200c9a66	17
1485068	polidocanol 1 % Injectable Foam	SY	dfd6b4a0-b0dc-11e2-9e96-0800200c9a66	17
1485068	polidocanol 180 MG per 18 ML Injectable Foam	SY	dfd6b4a0-b0dc-11e2-9e96-0800200c9a66	17
1485070	Varithena 1 % Injectable Foam	SY	dfd6b4a0-b0dc-11e2-9e96-0800200c9a66	17
1485070	Varithena 10 MG/ML Injectable Foam	SY	dfd6b4a0-b0dc-11e2-9e96-0800200c9a66	17
1485070	Varithena 180 MG per 18 ML Intravenous Foam	SY	dfd6b4a0-b0dc-11e2-9e96-0800200c9a66	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
60635-018-01	60635001801	18 mL in 1 CANISTER	18 ml	Historical
60635-123-01	60635012301	1 in 1 BOX		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Varithena - Boston Scientific Corporation	Boston Scientific Corporation	2026-05-05	HUMAN PRESCRIPTION DRUG LABEL	17