Xylocaine

In shortageOrange BookUNIISPLATC R02AD02

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeR02AD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6332349391
5 AMPULE in 1 BOX (63323-493-91) / 20 mL in 1 AMPULE (63323-493-01)
ndc11
6332349397
5 AMPULE in 1 BOX (63323-493-97) / 10 mL in 1 AMPULE (63323-493-03)

Annotations

UNII (FDA Substance ID)

EC2CNF7XFP

LIDOCAINE HYDROCHLORIDE ANHYDROUS

RxCUI 1299236

Orange Book

N006488

APAPAPAPAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Lidocaine Patch

Raw payload (JSON)

{
  "unii": {
    "unii": "EC2CNF7XFP",
    "rxcui": "1299236",
    "inchikey": "IYBQHJMYDGVZRY-UHFFFAOYSA-N",
    "display_name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
  "spl_meta": {
    "74bad838-2800-4d36-a3ee-cc1d739d24c2": {
      "match": "brand_token",
      "title": "XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SPORTPHARM LLC]",
      "spl_version": "1",
      "published_date": "2026-03-26"
    }
  },
  "productid": "63323-493_fa12a8e8-09fd-496f-8cc6-ffe0eb02e2df",
  "productndc": "63323-493",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "006488",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "2%",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.01MG/ML;2%",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.01MG/ML;1%",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.02MG/ML;2%",
        "product_no": "005",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1%",
        "product_no": "007",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.5%",
        "product_no": "008",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1.5%",
        "product_no": "010",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.005MG/ML;0.5%",
        "product_no": "012",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.005MG/ML;1.5%",
        "product_no": "017",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.005MG/ML;1%",
        "product_no": "018",
        "approval_date": "Nov 13, 1986"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.005MG/ML;2%",
        "product_no": "019",
        "approval_date": "Nov 13, 1986"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
  "shortage_reason": "Lidocaine Patch",
  "shortage_status": "current",
  "proprietary_name": "Xylocaine",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA006488",
  "marketing_category": "NDA",
  "nonproprietary_name": "LIDOCAINE HYDROCHLORIDE",
  "start_marketing_date": "20110718",
  "active_numerator_strength": "15"
}

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Other records sharing ATC code R02AD02.

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