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United States · US · US:66312-630_14eaeca2-d602-48eb-a384-eee02a9a1b04

Citanest Plain

Orange BookUNIISPLATC N01BB04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerDentsply Pharmaceutical Inc.
CountryUS (United States)
ATC codeN01BB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6631263014
    50 CARTRIDGE in 1 CARTON (66312-630-14) / 1.8 mL in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)
MJW015BAPH
PRILOCAINE HYDROCHLORIDE
RxCUI 2557
Orange Book
A079235
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "MJW015BAPH",
    "rxcui": "2557",
    "inchikey": "BJPJNTKRKALCPP-UHFFFAOYSA-N",
    "display_name": "PRILOCAINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBMUCOSAL",
  "spl_meta": {
    "801a4f80-397b-46c5-ad3e-a80594e7bda2": {
      "match": "brand_token",
      "title": "CITANEST FORTE DENTAL (PRILOCAINE HCL AND EPINEPHRINE) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA, INC.]",
      "spl_version": "1",
      "published_date": "2026-03-30"
    }
  },
  "productid": "66312-630_14eaeca2-d602-48eb-a384-eee02a9a1b04",
  "productndc": "66312-630",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "079235",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "4%",
        "product_no": "001",
        "approval_date": "Sep 29, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRILOCAINE HYDROCHLORIDE",
  "proprietary_name": "Citanest Plain",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA079235",
  "marketing_category": "ANDA",
  "nonproprietary_name": "prilocaine hydrochloride",
  "start_marketing_date": "19651118",
  "active_numerator_strength": "40"
}

Related drugs

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