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United States · US · US:83634-653_8fb1dd7b-f349-4a64-96c1-bd72bf748f3b

lidocaine hydrochloride

In shortageOrange BookUNIISPLATC R02AD02

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

Identification

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

Packs · 3

  • ndc11
    8363465302
    25 VIAL, SINGLE-DOSE in 1 CARTON (83634-653-02) / 2 mL in 1 VIAL, SINGLE-DOSE (83634-653-41)
  • ndc11
    8363465305
    25 VIAL, SINGLE-DOSE in 1 CARTON (83634-653-05) / 5 mL in 1 VIAL, SINGLE-DOSE (83634-653-42)
  • ndc11
    8363465330
    25 VIAL, SINGLE-DOSE in 1 CARTON (83634-653-30) / 30 mL in 1 VIAL, SINGLE-DOSE (83634-653-43)

Annotations

UNII (FDA Substance ID)
V13007Z41A
LIDOCAINE HYDROCHLORIDE
RxCUI 142440
Orange Book
A219535
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Lidocaine Hydrochloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "V13007Z41A",
    "rxcui": "142440",
    "inchikey": "YECIFGHRMFEPJK-UHFFFAOYSA-N",
    "display_name": "LIDOCAINE HYDROCHLORIDE",
    "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": "83634-653_8fb1dd7b-f349-4a64-96c1-bd72bf748f3b",
  "productndc": "83634-653",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "219535",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Apr 2, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2%",
        "product_no": "002",
        "approval_date": "Feb 6, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LIDOCAINE HYDROCHLORIDE",
  "shortage_reason": "Lidocaine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "lidocaine hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA219535",
  "marketing_category": "ANDA",
  "nonproprietary_name": "lidocaine hydrochloride",
  "start_marketing_date": "20251231",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R02AD02.

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