Articaine Hydrochloride and Epinephrine

Orange BookUNIISPLATC N01BB

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

Identification

ManufacturerBurkhart Dental Supply Co., Inc

CountryUS (United States)

ATC codeN01BB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4349881601
50 CARTRIDGE in 1 BOX (43498-816-01) / 1.8 mL in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)

QS9014Q792

ARTICAINE HYDROCHLORIDE

RxCUI 2117

Orange Book

N022466

DailyMed SPL labels

1 version tracked

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",
  "spl_meta": {
    "636cbf11-819c-48f8-915d-ac5fb38bd352": {
      "match": "brand_token",
      "title": "ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC.]",
      "spl_version": "1",
      "published_date": "2026-03-30"
    }
  },
  "productid": "43498-816_644fa9c3-1491-42e3-9194-9c562617fd06",
  "productndc": "43498-816",
  "dosage_form": "INJECTION, SOLUTION",
  "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": "Articaine Hydrochloride and Epinephrine",
  "active_ingred_unit": "mg/mL; ug/mL",
  "application_number": "NDA022466",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE",
  "start_marketing_date": "20241104",
  "active_numerator_strength": "40; 10"
}

Related drugs

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