Levoleucovorin

Orange BookUNIISPLATC V03AF04

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc.

CountryUS (United States)

ATC codeV03AF04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7128810518
1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-18) / 17.5 mL in 1 VIAL, SINGLE-DOSE
ndc11
7128810525
1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-25) / 25 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

778XL6VBS8

LEVOLEUCOVORIN CALCIUM

RxCUI 979509

Orange Book

A211002

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": "71288-105_17100790-fb82-43cd-80eb-b3e73d918bbd",
  "productndc": "71288-105",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "211002",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Aug 16, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 250MG BASE/25ML (EQ 10MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Aug 16, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOLEUCOVORIN CALCIUM",
  "proprietary_name": "Levoleucovorin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA211002",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levoleucovorin calcium",
  "start_marketing_date": "20190816",
  "active_numerator_strength": "10"
}

Related drugs

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