Nesacaine

Orange BookUNIIATC S01HA08

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeS01HA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332347727
25 VIAL, SINGLE-DOSE in 1 TRAY (63323-477-27) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-477-01)

Annotations

UNII (FDA Substance ID)

LT7Z1YW11H

CHLOROPROCAINE HYDROCHLORIDE

RxCUI 53616

Orange Book

N009435

APAPAP

Raw payload (JSON)

{
  "unii": {
    "unii": "LT7Z1YW11H",
    "rxcui": "53616",
    "inchikey": "SZKQYDBPUCZLRX-UHFFFAOYSA-N",
    "display_name": "CHLOROPROCAINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
  "productid": "63323-477_46570679-3557-4250-bb21-b406097e106d",
  "productndc": "63323-477",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "009435",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "2%",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2%",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "3%",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "2%",
        "product_no": "006",
        "approval_date": "May 2, 1996"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "3%",
        "product_no": "007",
        "approval_date": "May 2, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLOROPROCAINE HYDROCHLORIDE",
  "proprietary_name": "Nesacaine",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA009435",
  "marketing_category": "NDA",
  "nonproprietary_name": "CHLOROPROCAINE HYDROCHLORIDE",
  "start_marketing_date": "20101014",
  "active_numerator_strength": "20"
}

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