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United States · US · US:0409-9042_6e442bfd-d3da-4913-8585-ce3485644364

Bupivacaine Hydrochloride and Epinephrine

In shortageOrange BookUNIISPLATC N01BB

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

Identification

ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeN01BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0409904201
    10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9042-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9042-11)
  • ndc11
    0409904217
    25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9042-17) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-9042-16)

Annotations

UNII (FDA Substance ID)
7TQO7W3VT8
BUPIVACAINE HYDROCHLORIDE
RxCUI 267396
Orange Book
A071165
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; INFILTRATION; 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": "0409-9042_6e442bfd-d3da-4913-8585-ce3485644364",
  "productndc": "0409-9042",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "071165",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "0.25%;0.005MG/ML",
        "product_no": "001",
        "approval_date": "Jun 16, 1988"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
  "shortage_reason": "Bupivacaine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Bupivacaine Hydrochloride and Epinephrine",
  "active_ingred_unit": "mg/mL; ug/mL",
  "application_number": "ANDA071165",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE",
  "start_marketing_date": "20050615",
  "active_numerator_strength": "2.5; 5"
}

Related drugs

Other records sharing ATC code N01BB.

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