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United States · US · US:51004-5801_8f96de1c-fc45-4d2b-963c-1eadf85bd164

Citanest Forte DENTAL

In shortageOrange BookUNIISPLATC A01AD

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

Identification

ManufacturerNovocol Pharmaceutical of Canada, Inc.
CountryUS (United States)
ATC codeA01AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5100458016
    50 CARTRIDGE in 1 CARTON (51004-5801-6) / 1.8 mL in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)
30Q7KI53AK
EPINEPHRINE BITARTRATE
RxCUI 203180
Orange Book
A078959
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Epinephrine Bitartrate, Lidocaine Hydrochloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "30Q7KI53AK",
    "rxcui": "203180",
    "inchikey": "YLXIPWWIOISBDD-NDAAPVSOSA-N",
    "display_name": "EPINEPHRINE BITARTRATE",
    "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": "51004-5801_8f96de1c-fc45-4d2b-963c-1eadf85bd164",
  "productndc": "51004-5801",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "078959",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.005MG/ML;4%",
        "product_no": "001",
        "approval_date": "Aug 30, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE",
  "shortage_reason": "Epinephrine Bitartrate, Lidocaine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Citanest Forte DENTAL",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA078959",
  "marketing_category": "ANDA",
  "nonproprietary_name": "prilocaine hcl and epinephrine",
  "start_marketing_date": "20171204",
  "active_numerator_strength": ".005; 40"
}

Related drugs

Other records sharing ATC code A01AD.

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