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United States · US · US:0362-9011_a427016b-7421-413c-85fc-64f583ebe336

Vivacaine

In shortageOrange BookUNIISPLATC N01BB

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

Identification

ManufacturerSeptodont, Inc.
CountryUS (United States)
ATC codeN01BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0362901150
    50 CARTRIDGE in 1 CARTON (0362-9011-50) / 1.8 mL in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)
AKA908P8J1
BUPIVACAINE HYDROCHLORIDE ANHYDROUS
RxCUI 1375412
Orange Book
A077250
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "AKA908P8J1",
    "rxcui": "1375412",
    "inchikey": "SIEYLFHKZGLBNX-UHFFFAOYSA-N",
    "display_name": "BUPIVACAINE HYDROCHLORIDE ANHYDROUS",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBMUCOSAL",
  "spl_meta": {
    "b4c60d8e-e350-45b2-9d6b-5815eeb6c994": {
      "match": "brand_token",
      "title": "VIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]",
      "spl_version": "11",
      "published_date": "2024-02-19"
    }
  },
  "productid": "0362-9011_a427016b-7421-413c-85fc-64f583ebe336",
  "productndc": "0362-9011",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "077250",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "0.5%;0.0091MG/ML",
        "product_no": "001",
        "approval_date": "Sep 27, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE",
  "shortage_reason": "Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection",
  "shortage_status": "current",
  "proprietary_name": "Vivacaine",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA077250",
  "marketing_category": "ANDA",
  "nonproprietary_name": "bupivacaine hydrochloride and epinephrine bitartrate",
  "start_marketing_date": "20130601",
  "active_numerator_strength": "5; .005"
}

Related drugs

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