KHAPZORY

Orange BookUNIISPL

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

Identification

ManufacturerAcrotech Biopharma Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7289300401
1 VIAL in 1 CARTON (72893-004-01) / 3.5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

5TXQ76K65T

LEVOLEUCOVORIN DISODIUM

RxCUI 2107308

Orange Book

N211226

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5TXQ76K65T",
    "rxcui": "2107308",
    "inchikey": "FSDMNNPYPVJNAT-NJHZPMQHSA-L",
    "display_name": "LEVOLEUCOVORIN DISODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "344f65ac-9f04-49d7-b7c3-4ba19bd7b429": {
      "match": "brand_token",
      "title": "KHAPZORY (LEVOLEUCOVORIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACROTECH BIOPHARMA INC]",
      "spl_version": "12",
      "published_date": "2026-03-18"
    }
  },
  "productid": "72893-004_4b8997a9-ddf8-4618-966a-291d583f24f7",
  "productndc": "72893-004",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "211226",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "175MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 19, 2018"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "300MG/VIAL",
        "product_no": "002",
        "approval_date": "Oct 19, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOLEUCOVORIN DISODIUM",
  "proprietary_name": "KHAPZORY",
  "active_ingred_unit": "mg/3.5mL",
  "application_number": "NDA211226",
  "marketing_category": "NDA",
  "nonproprietary_name": "levoleucovorin",
  "start_marketing_date": "20190102",
  "active_numerator_strength": "175"
}

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