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United States · US · US:0409-3613_7a09a90d-26da-42bd-bb54-2d2102eb8c1c

Bupivacaine

In shortageOrange BookUNIISPLATC N01BB01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeN01BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0409361301
    10 AMPULE in 1 CARTON (0409-3613-01) / 2 mL in 1 AMPULE (0409-3613-11)

Annotations

UNII (FDA Substance ID)
7TQO7W3VT8
BUPIVACAINE HYDROCHLORIDE
RxCUI 267396
Orange Book
A071810
AP
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": "SUBARACHNOID",
  "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": "0409-3613_7a09a90d-26da-42bd-bb54-2d2102eb8c1c",
  "productndc": "0409-3613",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "071810",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.75%",
        "product_no": "001",
        "approval_date": "Dec 11, 1987"
      }
    ],
    "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",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA071810",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BUPIVACAINE HYDROCHLORIDE IN DEXTROSE",
  "start_marketing_date": "20050131",
  "active_numerator_strength": "7.5"
}

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