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United States · US · US:0362-1098_104f9a5f-ec7b-4caa-b357-ff7cc18cfc90

Scandonest 3% Plain

Orange BookUNIISPLATC N01BB03

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

Identification

ManufacturerSeptodont, Inc.
CountryUS (United States)
ATC codeN01BB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0362109890
    5 BLISTER PACK in 1 CARTON (0362-1098-90) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)
4VFX2L7EM5
MEPIVACAINE HYDROCHLORIDE
RxCUI 203185
Orange Book
A088387
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4VFX2L7EM5",
    "rxcui": "203185",
    "inchikey": "RETIMRUQNCDCQB-UHFFFAOYSA-N",
    "display_name": "MEPIVACAINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "af6ff5f6-7221-421b-9b7c-8fcee4a47772": {
      "match": "brand_token",
      "title": "SCANDONEST 3% PLAIN (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [SEPTODONT, INC.]",
      "spl_version": "6",
      "published_date": "2025-06-02"
    }
  },
  "productid": "0362-1098_104f9a5f-ec7b-4caa-b357-ff7cc18cfc90",
  "productndc": "0362-1098",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "088387",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "3%",
        "product_no": "001",
        "approval_date": "Oct 10, 1984"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEPIVACAINE HYDROCHLORIDE",
  "proprietary_name": "Scandonest 3% Plain",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA088387",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mepivacaine Hydrochloride",
  "start_marketing_date": "20171222",
  "active_numerator_strength": "30"
}

Related drugs

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