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United States · US · US:51662-1590_08669a95-8c7b-9ad0-e063-6394a90adba2

XYLOCAINE

In shortageOrange BookUNIISPLATC R02AD02

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeR02AD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5166215903
    25 POUCH in 1 CASE (51662-1590-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1590-2) / 50 mL in 1 VIAL, MULTI-DOSE (51662-1590-1)

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 Hydrochloride Injection
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": "INFILTRATION; 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": "51662-1590_08669a95-8c7b-9ad0-e063-6394a90adba2",
  "productndc": "51662-1590",
  "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 Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "XYLOCAINE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA006488",
  "marketing_category": "NDA",
  "nonproprietary_name": "XYLOCAINE",
  "start_marketing_date": "20220713",
  "active_numerator_strength": "20"
}

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