XYLOCAINE

In shortageOrange BookUNIISPLATC A01AD

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst

CountryUS (United States)

ATC codeA01AD

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5166216223
25 POUCH in 1 CASE (51662-1622-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1622-2) / 10 mL in 1 VIAL, MULTI-DOSE (51662-1622-1)

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": "51662-1622_199a3180-9d2b-2308-e063-6294a90ae9fd",
  "productndc": "51662-1622",
  "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": "XYLOCAINE",
  "start_marketing_date": "20100812",
  "active_numerator_strength": ".01; 10"
}

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