Marcaine with Epinephrine

In shortageOrange BookUNIISPLATC N01BB

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

Identification

ManufacturerHospira, Inc.

CountryUS (United States)

ATC codeN01BB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0409175550
1 VIAL, MULTI-DOSE in 1 CARTON (0409-1755-50) / 50 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)

7TQO7W3VT8

BUPIVACAINE HYDROCHLORIDE

RxCUI 267396

Orange Book

N016964

APAPAPAPAPAPAPAP

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": {
    "67578b56-7540-487e-1fba-481255620e78": {
      "match": "brand_token",
      "title": "MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "38",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0409-1755_7040888c-2cde-4408-af99-d249985f8444",
  "productndc": "0409-1755",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "016964",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.25%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.25%;0.0091MG/ML",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.5%",
        "product_no": "005",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.5%",
        "product_no": "006",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.5%;0.0091MG/ML",
        "product_no": "007",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.5%;0.0091MG/ML",
        "product_no": "008",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.75%",
        "product_no": "009",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.75%;0.0091MG/ML",
        "product_no": "010",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.25%",
        "product_no": "012",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.25%;0.0091MG/ML",
        "product_no": "013",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
  "shortage_reason": "Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection",
  "shortage_status": "current",
  "proprietary_name": "Marcaine with Epinephrine",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA016964",
  "marketing_category": "NDA",
  "nonproprietary_name": "BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE",
  "start_marketing_date": "20060322",
  "active_numerator_strength": "5; .0091"
}

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