Bupivacaine

In shortageOrange BookUNIISPLATC N01BB01

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

Identification

ManufacturerJiangsu Hengrui Pharmaceuticals Co., Ltd.

CountryUS (United States)

ATC codeN01BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5788432521
10 VIAL in 1 CARTON (57884-3252-1) / 20 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

Y8335394RO

BUPIVACAINE

RxCUI 1815

Orange Book

A214348

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "Y8335394RO",
    "rxcui": "1815",
    "inchikey": "LEBVLXFERQHONN-UHFFFAOYSA-N",
    "display_name": "BUPIVACAINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INFILTRATION",
  "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": "57884-3252_1c5d9dbb-0d16-6893-e063-6394a90ad989",
  "productndc": "57884-3252",
  "dosage_form": "INJECTION, SUSPENSION, LIPOSOMAL",
  "orange_book": {
    "appl_no": "214348",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "133MG/10ML (13.3MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 1, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "266MG/20ML (13.3MG/ML)",
        "product_no": "002",
        "approval_date": "Jul 1, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPIVACAINE",
  "shortage_reason": "Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection",
  "shortage_status": "current",
  "proprietary_name": "Bupivacaine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA214348",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bupivacaine",
  "start_marketing_date": "20240701",
  "active_numerator_strength": "13.3"
}

Related drugs

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