asclera

Generic: polidocanol

Labeler: methapharm, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name asclera
Generic Name polidocanol
Labeler methapharm, inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

polidocanol .005 g/mL

Manufacturer
Methapharm, Inc

Identifiers & Regulatory

Product NDC 67850-140
Product ID 67850-140_f443bbaf-ef8e-4f9e-ba4c-6f87dc58a671
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021201
Listing Expiration 2026-12-31
Marketing Start 2010-06-01

Pharmacologic Class

Established (EPC)
sclerosing agent [epc]
Mechanism of Action
sclerosing activity [moa]
Physiologic Effect
vascular sclerosing activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67850140
Hyphenated Format 67850-140

Supplemental Identifiers

RxCUI
968173 968177 968181 968183
UPC
0367850141056 0367850140059
UNII
0AWH8BFG9A
NUI
N0000175814 N0000020024 N0000009905

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name asclera (source: ndc)
Generic Name polidocanol (source: ndc)
Application Number NDA021201 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .005 g/mL
source: ndc
Packaging
  • 2 mL in 1 AMPULE (67850-140-05)
source: ndc

Packages (1)

67850-140-05 2 mL in 1 AMPULE (67850-140-05)

Ingredients (1)

polidocanol (.005 g/mL)

Linked Drug Pages (1)

Asclera ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f443bbaf-ef8e-4f9e-ba4c-6f87dc58a671", "openfda": {"nui": ["N0000175814", "N0000020024", "N0000009905"], "upc": ["0367850141056", "0367850140059"], "unii": ["0AWH8BFG9A"], "rxcui": ["968173", "968177", "968181", "968183"], "spl_set_id": ["bb1f342b-5352-4059-a0b2-e60fd652fd28"], "pharm_class_pe": ["Vascular Sclerosing Activity [PE]"], "pharm_class_epc": ["Sclerosing Agent [EPC]"], "pharm_class_moa": ["Sclerosing Activity [MoA]"], "manufacturer_name": ["Methapharm, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 AMPULE (67850-140-05)", "package_ndc": "67850-140-05", "marketing_start_date": "20220201"}], "brand_name": "Asclera", "product_id": "67850-140_f443bbaf-ef8e-4f9e-ba4c-6f87dc58a671", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Sclerosing Activity [MoA]", "Sclerosing Agent [EPC]", "Vascular Sclerosing Activity [PE]"], "product_ndc": "67850-140", "generic_name": "POLIDOCANOL", "labeler_name": "Methapharm, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Asclera", "active_ingredients": [{"name": "POLIDOCANOL", "strength": ".005 g/mL"}], "application_number": "NDA021201", "marketing_category": "NDA", "marketing_start_date": "20100601", "listing_expiration_date": "20261231"}