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United States · US · US:66312-181_5b7b5a3e-e9fe-4dd1-949f-d3cac9755bb5

Xylocaine

In shortageOrange BookUNIISPLATC A01AD

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

Identification

ManufacturerDentsply Pharmaceutical
CountryUS (United States)
ATC codeA01AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6631218116
    50 CARTRIDGE in 1 CARTON (66312-181-16) / 1.7 mL in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)
30Q7KI53AK
EPINEPHRINE BITARTRATE
RxCUI 203180
Orange Book
A088389
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Epinephrine Bitartrate, Lidocaine Hydrochloride 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": "SUBMUCOSAL",
  "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": "66312-181_5b7b5a3e-e9fe-4dd1-949f-d3cac9755bb5",
  "productndc": "66312-181",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "088389",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.02MG BASE/ML;2%",
        "product_no": "001",
        "approval_date": "Jan 22, 1985"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE",
  "shortage_reason": "Epinephrine Bitartrate, Lidocaine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Xylocaine",
  "active_ingred_unit": "ug/mL; mg/mL",
  "application_number": "ANDA088389",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lidocaine Hydrochloride and Epinephrine Bitartrate",
  "start_marketing_date": "19850122",
  "active_numerator_strength": "20; 20"
}

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