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 · 0

No packs registered.

Annotations

UNII (FDA Substance ID)

778XL6VBS8

LEVOLEUCOVORIN CALCIUM

RxCUI 979509

Orange Book

A211003

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": "71288-104_a0d839ca-80eb-4061-a0c4-30e5d94af094",
  "productndc": "71288-104",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "211003",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Aug 22, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOLEUCOVORIN CALCIUM",
  "proprietary_name": "Levoleucovorin",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA211003",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levoleucovorin calcium",
  "start_marketing_date": "20190822",
  "active_numerator_strength": "50"
}

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