Bupivacaine Hydrochloride

In shortageOrange BookUNIISPLATC N01BB01

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeN01BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7642056110
10 mL in 1 VIAL, SINGLE-DOSE (76420-561-10)

Annotations

UNII (FDA Substance ID)

7TQO7W3VT8

BUPIVACAINE HYDROCHLORIDE

RxCUI 267396

Orange Book

A204842

APAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Bupivacaine Hydrochloride 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": "76420-561_028b204a-e3a0-ea94-e063-6294a90ad70e",
  "productndc": "76420-561",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "204842",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.25%",
        "product_no": "001",
        "approval_date": "Feb 11, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.5%",
        "product_no": "002",
        "approval_date": "Feb 11, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.75%",
        "product_no": "003",
        "approval_date": "Feb 11, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPIVACAINE HYDROCHLORIDE",
  "shortage_reason": "Bupivacaine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Bupivacaine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA204842",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bupivacaine Hydrochloride",
  "start_marketing_date": "20210211",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N01BB01.

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