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United States · US · US:67850-141_f443bbaf-ef8e-4f9e-ba4c-6f87dc58a671
Asclera
Orange BookUNIISPLATC C05BB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMethapharm, Inc
CountryUS (United States)
ATC codeC05BB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167850141052 mL in 1 AMPULE (67850-141-05)
Annotations
UNII (FDA Substance ID)
0AWH8BFG9A
POLIDOCANOL
RxCUI 968170
Orange Book
N021201
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0AWH8BFG9A",
"rxcui": "968170",
"inchikey": null,
"display_name": "POLIDOCANOL",
"substance_type": "polymer",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"bb1f342b-5352-4059-a0b2-e60fd652fd28": {
"match": "brand_token",
"title": "ASCLERA (POLIDOCANOL) INJECTION, SOLUTION [METHAPHARM, INC]",
"spl_version": "26",
"published_date": "2025-07-18"
}
},
"productid": "67850-141_f443bbaf-ef8e-4f9e-ba4c-6f87dc58a671",
"productndc": "67850-141",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "021201",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG/2ML (5MG/ML)",
"product_no": "001",
"approval_date": "Mar 30, 2010"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20MG/2ML (10MG/ML)",
"product_no": "002",
"approval_date": "Mar 30, 2010"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "POLIDOCANOL",
"proprietary_name": "Asclera",
"active_ingred_unit": "g/mL",
"application_number": "NDA021201",
"marketing_category": "NDA",
"nonproprietary_name": "POLIDOCANOL",
"start_marketing_date": "20100601",
"active_numerator_strength": ".01"
}Related drugs
Other records sharing ATC code C05BB02.
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