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United States · US · US:65282-1605_447bfde4-fff3-32a6-e063-6394a90a667e

Lidocaine Hydrochloride

In shortageOrange BookUNIISPLATC R02AD02

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

Identification

ManufacturerSpectra Medical Devices, LLC
CountryUS (United States)
ATC codeR02AD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6528216051
    25 AMPULE in 1 CARTON (65282-1605-1) / 5 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)
EC2CNF7XFP
LIDOCAINE HYDROCHLORIDE ANHYDROUS
RxCUI 1299236
Orange Book
A208017
AP
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": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
  "spl_meta": {
    "4db609cc-f329-62a4-e063-6394a90aefc1": {
      "match": "brand_token",
      "title": "LIDOCAINE GEL [YYBA CORP]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "65282-1605_447bfde4-fff3-32a6-e063-6394a90a667e",
  "productndc": "65282-1605",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "208017",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Apr 18, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
  "shortage_reason": "Lidocaine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Lidocaine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA208017",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
  "start_marketing_date": "20180418",
  "active_numerator_strength": "10"
}

Related drugs

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