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United States · US · US:0409-3183_c8636a3b-5a45-4584-a9ea-85f506901337

Lidocaine Hydrochloride and Epinephrine

Orange BookUNIISPLATC A01AD

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

Identification

ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeA01AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0409318301
    5 VIAL, SINGLE-DOSE in 1 CARTON (0409-3183-01) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-3183-11)

Annotations

UNII (FDA Substance ID)
YKH834O4BH
EPINEPHRINE
RxCUI 3992
Orange Book
A089651
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "YKH834O4BH",
    "rxcui": "3992",
    "inchikey": "UCTWMZQNUQWSLP-VIFPVBQESA-N",
    "display_name": "EPINEPHRINE",
    "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": "0409-3183_c8636a3b-5a45-4584-a9ea-85f506901337",
  "productndc": "0409-3183",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "089651",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.005MG/ML;2%",
        "product_no": "001",
        "approval_date": "Jun 21, 1988"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPINEPHRINE; LIDOCAINE HYDROCHLORIDE",
  "proprietary_name": "Lidocaine Hydrochloride and Epinephrine",
  "active_ingred_unit": "ug/mL; mg/mL",
  "application_number": "ANDA089651",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LIDOCAINE HYDROCHLORIDE and EPINEPHRINE",
  "start_marketing_date": "20050706",
  "active_numerator_strength": "5; 20"
}

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