Articadent

Orange BookUNIISPLATC N01BB

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

Identification

ManufacturerDentsply Pharmaceutical

CountryUS (United States)

ATC codeN01BB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6631260216
50 CARTRIDGE in 1 CARTON (66312-602-16) / 1.7 mL in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)

QS9014Q792

ARTICAINE HYDROCHLORIDE

RxCUI 2117

Orange Book

N020971

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": {
    "9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00": {
      "match": "brand_token",
      "title": "ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL]",
      "spl_version": "9",
      "published_date": "2024-03-04"
    }
  },
  "productid": "66312-602_7b56ec0a-5b85-4069-a3b2-94654644aaa4",
  "productndc": "66312-602",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020971",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Apr 3, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Mar 30, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
  "proprietary_name": "Articadent",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA020971",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Articaine hydrochloride and Epinephrine Bitartrate",
  "start_marketing_date": "20090901",
  "active_numerator_strength": "40; .005"
}

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