BUPIVACAINE HCl

In shortageOrange BookUNIISPLATC N01BB01

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst

CountryUS (United States)

ATC codeN01BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5166215883
25 POUCH in 1 CASE (51662-1588-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1588-2) / 50 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)

7TQO7W3VT8

BUPIVACAINE HYDROCHLORIDE

RxCUI 267396

Orange Book

N018304

APAPAPAPAP

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": "51662-1588_0ff9d690-ca06-4e75-e063-6394a90afd2a",
  "productndc": "51662-1588",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "018304",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "0.25%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "0.5%",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "0.75%",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "0.5%;0.0091MG/ML",
        "product_no": "004",
        "approval_date": "Sep 2, 1983"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "0.75%;0.0091MG/ML",
        "product_no": "005",
        "approval_date": "Sep 2, 1983"
      }
    ],
    "appl_type": "N"
  },
  "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": "NDA018304",
  "marketing_category": "NDA",
  "nonproprietary_name": "BUPIVACAINE HCl",
  "start_marketing_date": "20220711",
  "active_numerator_strength": "5"
}

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