Orabloc

Orange BookUNIIATC N01BB

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPierrel S.p.A.

CountryUS (United States)

ATC codeN01BB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4514612001
100 CARTRIDGE in 1 BOX (45146-120-01) / 1.8 mL in 1 CARTRIDGE
ndc11
4514612002
50 CARTRIDGE in 1 BOX (45146-120-02) / 1.8 mL in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)

QS9014Q792

ARTICAINE HYDROCHLORIDE

RxCUI 2117

Orange Book

N022466

Raw payload (JSON)

{
  "unii": {
    "unii": "QS9014Q792",
    "rxcui": "2117",
    "inchikey": "GDWDBGSWGNEMGJ-UHFFFAOYSA-N",
    "display_name": "ARTICAINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBMUCOSAL",
  "productid": "45146-120_df09bf36-46b3-4edf-9a11-9d12bb7e12b3",
  "productndc": "45146-120",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "022466",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Feb 26, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Feb 26, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
  "proprietary_name": "Orabloc",
  "active_ingred_unit": "mg/mL; ug/mL",
  "application_number": "NDA022466",
  "marketing_category": "NDA",
  "nonproprietary_name": "articaine hydrochloride and epinephrine bitartrate",
  "start_marketing_date": "20110301",
  "active_numerator_strength": "40; 5"
}

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