Xylocaine

In shortageOrange BookUNIISPLATC A01AD

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeA01AD

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009068510
25 VIAL, MULTI-DOSE in 1 TRAY (50090-6851-0) / 20 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)

30Q7KI53AK

EPINEPHRINE BITARTRATE

RxCUI 203180

Orange Book

N006488

APAPAPAPAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Epinephrine Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "30Q7KI53AK",
    "rxcui": "203180",
    "inchikey": "YLXIPWWIOISBDD-NDAAPVSOSA-N",
    "display_name": "EPINEPHRINE BITARTRATE",
    "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": "50090-6851_64eae69a-c01a-49c4-93d1-333b26983809",
  "productndc": "50090-6851",
  "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": "EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS",
  "shortage_reason": "Epinephrine Injection",
  "shortage_status": "current",
  "proprietary_name": "Xylocaine",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA006488",
  "marketing_category": "NDA",
  "nonproprietary_name": "LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE",
  "start_marketing_date": "20100812",
  "active_numerator_strength": ".01; 20"
}

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