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United States · US · US:73293-0002_2e641a0d-4d42-e7cd-e063-6394a90a47d4

Bupivacaine Hydrochloride

In shortageOrange BookUNIISPLATC N01BB01

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

Identification

ManufacturerHuons Co., Ltd.
CountryUS (United States)
ATC codeN01BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7329300022
    50 AMPULE in 1 PACKAGE (73293-0002-2) / 2 mL in 1 AMPULE (73293-0002-1)

Annotations

UNII (FDA Substance ID)
7TQO7W3VT8
BUPIVACAINE HYDROCHLORIDE
RxCUI 267396
Orange Book
A212822
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "7TQO7W3VT8",
    "rxcui": "267396",
    "inchikey": "HUCIWBPMHXGLFM-UHFFFAOYSA-N",
    "display_name": "BUPIVACAINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBARACHNOID",
  "spl_meta": {
    "8f8f4ece-de78-4c13-8d9f-c3bb7053019d": {
      "match": "brand_token",
      "title": "BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]",
      "spl_version": "17",
      "published_date": "2026-04-30"
    }
  },
  "productid": "73293-0002_2e641a0d-4d42-e7cd-e063-6394a90a47d4",
  "productndc": "73293-0002",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "212822",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.75%",
        "product_no": "001",
        "approval_date": "Dec 30, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPIVACAINE HYDROCHLORIDE",
  "shortage_reason": "Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection",
  "shortage_status": "current",
  "proprietary_name": "Bupivacaine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA212822",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bupivacaine hydrochloride",
  "start_marketing_date": "20191230",
  "active_numerator_strength": "7.5"
}

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