Home NDC 67850-140 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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 67850-140 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 67850-140 67850-140-05 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 N021201-001 ASCLERA POLIDOCANOL 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 N021201-002 ASCLERA POLIDOCANOL 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30
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 · 82 observed 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 2026-02-19 14:30 UTC 2026-02 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Asclera
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLIDOCANOL .005 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0AWH8BFG9A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 968173 Internal RxNorm lookup 968177 Internal RxNorm lookup 968181 Internal RxNorm lookup 968183 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67850-140-05 Asclera 2 mL in 1 AMPULE INJECTION, SOLUTION 2 26
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67850-140 ASCLERA (POLIDOCANOL) INJECTION, SOLUTION [METHAPHARM, INC] 25 Current NDC, Legacy NDC, 1 package rows 20250117_bb1f342b-5352-4059-a0b2-e60fd652fd28.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 67850-140-05 67850014005 2 mL in 1 AMPULE (67850-140-05) 2 ml 2022-02-01 0000-00-00 No No Current