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United States · US · US:43598-773_2f5844a8-825f-6a4f-996e-17e21c369359

LEVOLEUCOVORIN

Orange BookUNIISPLATC V03AF04

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

Identification

ManufacturerDr.Reddy's Laboratories Inc
CountryUS (United States)
ATC codeV03AF04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4359877311
    1 VIAL, SINGLE-DOSE in 1 CARTON (43598-773-11) / 25 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
778XL6VBS8
LEVOLEUCOVORIN CALCIUM
RxCUI 979509
Orange Book
A210892
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "778XL6VBS8",
    "rxcui": "979509",
    "inchikey": "KVUAALJSMIVURS-QNTKWALQSA-L",
    "display_name": "LEVOLEUCOVORIN CALCIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "0c67eeae-3090-473d-b712-b9a83dc77b72": {
      "match": "brand_token",
      "title": "LEVOLEUCOVORIN CALCIUM (LEVOLEUCOVORIN) INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "12",
      "published_date": "2024-08-08"
    }
  },
  "productid": "43598-773_2f5844a8-825f-6a4f-996e-17e21c369359",
  "productndc": "43598-773",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210892",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Sep 14, 2018"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 250MG BASE/25ML (EQ 10MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Sep 14, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOLEUCOVORIN CALCIUM",
  "proprietary_name": "LEVOLEUCOVORIN",
  "active_ingred_unit": "mg/25mL",
  "application_number": "ANDA210892",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LEVOLEUCOVORIN",
  "start_marketing_date": "20180926",
  "active_numerator_strength": "250"
}

Related drugs

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