Leucovorin Calcium

Orange BookUNIISPLATC V03AF03

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

Identification

ManufacturerSlate Run Pharmaceuticals, LLC

CountryUS (United States)

ATC codeV03AF03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7043611980
1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70436-119-80)

Annotations

UNII (FDA Substance ID)

RPR1R4C0P4

LEUCOVORIN CALCIUM

RxCUI 225852

Orange Book

A217021

APAPAPAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "RPR1R4C0P4",
    "rxcui": "225852",
    "inchikey": "KVUAALJSMIVURS-ZEDZUCNESA-L",
    "display_name": "LEUCOVORIN CALCIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "94669fc8-3c1c-4228-be27-09a1cd468c36": {
      "match": "brand_token",
      "title": "LEUCOVORIN CALCIUM TABLET [TEVA PHARMACEUTICALS USA, INC.]",
      "spl_version": "18",
      "published_date": "2026-04-21"
    }
  },
  "productid": "70436-119_2a4aaed3-885e-bc10-e063-6294a90a61af",
  "productndc": "70436-119",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "217021",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jul 10, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jul 10, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 200MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "Jul 10, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "004",
        "approval_date": "Jul 10, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 350MG BASE/VIAL",
        "product_no": "005",
        "approval_date": "Dec 19, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEUCOVORIN CALCIUM",
  "proprietary_name": "Leucovorin Calcium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217021",
  "marketing_category": "ANDA",
  "nonproprietary_name": "leucovorin calcium",
  "start_marketing_date": "20241227",
  "active_numerator_strength": "350"
}

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