BUPIVACAINE HCl

In shortageOrange BookUNIISPLATC N01BB01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerXellia Pharmaceuticals USA LLC

CountryUS (United States)

ATC codeN01BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7059411501
30 mL in 1 VIAL, SINGLE-DOSE (70594-115-01)

Annotations

UNII (FDA Substance ID)

7TQO7W3VT8

BUPIVACAINE HYDROCHLORIDE

RxCUI 267396

Orange Book

A091487

APAPAP

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": "EPIDURAL; INTRACAUDAL; PERINEURAL",
  "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": "70594-115_afc179ac-71b9-4021-8b71-3372bf590e4a",
  "productndc": "70594-115",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "091487",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Oct 18, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.25%",
        "product_no": "002",
        "approval_date": "Oct 18, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.75%",
        "product_no": "003",
        "approval_date": "Oct 18, 2011"
      }
    ],
    "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 HCl",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA091487",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bupivacaine hydrochloride",
  "start_marketing_date": "20230601",
  "active_numerator_strength": "2.5"
}

Related drugs

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