Bupivacaine Hydrochloride

In shortageOrange BookUNIISPLATC N01BB01

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeN01BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009045160
50 mL in 1 VIAL, MULTI-DOSE (50090-4516-0)

Annotations

UNII (FDA Substance ID)

7TQO7W3VT8

BUPIVACAINE HYDROCHLORIDE

RxCUI 267396

Orange Book

A207183

APAP

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": "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": "50090-4516_c7485abb-d059-4e91-8cd2-215cb93828ce",
  "productndc": "50090-4516",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "207183",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.25%",
        "product_no": "001",
        "approval_date": "May 13, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.5%",
        "product_no": "002",
        "approval_date": "May 13, 2016"
      }
    ],
    "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": "ANDA207183",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bupivacaine Hydrochloride",
  "start_marketing_date": "20160513",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N01BB01.

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