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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

  • ndc11
    6785014105
    2 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"
}

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