Asclera

Product NDC
67850-140
11-digit product format
678500140
Labeler code
67850
Product ID
67850-140_f443bbaf-ef8e-4f9e-ba4c-6f87dc58a671
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POLIDOCANOL
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Methapharm, Inc
Application
NDA021201
Marketing category
NDA
Marketing start
2010-06-01
Substance
POLIDOCANOL
Active strength
.005 g/mL
Pharmacologic classes
Sclerosing Activity [MoA], Sclerosing Agent [EPC], Vascular Sclerosing Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Asclera
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLIDOCANOL.005 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0AWH8BFG9A
Rxcui968173, 968177, 968181, 968183

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
2d2ef081-4f0c-4669-81e8-32b263669a0aProduct name120230801
af534dc0-c9e5-19a6-693c-e7ad53714660Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67850-140-05Asclera2 mL in 1 AMPULEINJECTION, SOLUTION226

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67850-140-05ML - Milliliter67850-140b2a7a9bd-0807-41c3-a9a8-6f1c2e6f992912022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67850-140ASCLERA (POLIDOCANOL) INJECTION, SOLUTION [METHAPHARM, INC]25Current NDC, Legacy NDC, 1 package rows20250117_bb1f342b-5352-4059-a0b2-e60fd652fd28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968177ASCLERA 10 MG in 2 ML InjectionPSNbb1f342b-5352-4059-a0b2-e60fd652fd2826
968183ASCLERA 20 MG in 2 ML InjectionPSNbb1f342b-5352-4059-a0b2-e60fd652fd2826
968173polidocanol 10 MG in 2 ML InjectionPSNbb1f342b-5352-4059-a0b2-e60fd652fd2826
968181polidocanol 20 MG in 2 ML InjectionPSNbb1f342b-5352-4059-a0b2-e60fd652fd2826
9681832 ML polidocanol 10 MG/ML Injection [Asclera]SBDbb1f342b-5352-4059-a0b2-e60fd652fd2826
9681772 ML polidocanol 5 MG/ML Injection [Asclera]SBDbb1f342b-5352-4059-a0b2-e60fd652fd2826
9681812 ML polidocanol 10 MG/ML InjectionSCDbb1f342b-5352-4059-a0b2-e60fd652fd2826
9681732 ML polidocanol 5 MG/ML InjectionSCDbb1f342b-5352-4059-a0b2-e60fd652fd2826
9681832 ML Asclera 10 MG/ML InjectionSYbb1f342b-5352-4059-a0b2-e60fd652fd2826
9681772 ML Asclera 5 MG/ML InjectionSYbb1f342b-5352-4059-a0b2-e60fd652fd2826
968177Asclera 0.5 % InjectionSYbb1f342b-5352-4059-a0b2-e60fd652fd2826
968183Asclera 1 % InjectionSYbb1f342b-5352-4059-a0b2-e60fd652fd2826
968177Asclera 10 MG per 2 ML InjectionSYbb1f342b-5352-4059-a0b2-e60fd652fd2826
968183Asclera 20 MG per 2 ML InjectionSYbb1f342b-5352-4059-a0b2-e60fd652fd2826
968173polidocanol 0.5 % InjectionSYbb1f342b-5352-4059-a0b2-e60fd652fd2826
968181polidocanol 1 % InjectionSYbb1f342b-5352-4059-a0b2-e60fd652fd2826
968173polidocanol 10 MG per 2 ML InjectionSYbb1f342b-5352-4059-a0b2-e60fd652fd2826
968181polidocanol 20 MG per 2 ML InjectionSYbb1f342b-5352-4059-a0b2-e60fd652fd2826

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67850-140-05678500140052 mL in 1 AMPULE (67850-140-05) 2 ml2022-02-010000-00-00NoNoCurrent