LEUCOVORIN CALCIUM

Orange BookUNIISPLATC V03AF03

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

Identification

ManufacturerMylan Institutional LLC

CountryUS (United States)

ATC codeV03AF03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6745752920
1 VIAL, SINGLE-DOSE in 1 CARTON (67457-529-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

RPR1R4C0P4

LEUCOVORIN CALCIUM

RxCUI 225852

Orange Book

A203800

APAPAP

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": "67457-529_2890b03c-dbef-4db8-8b07-c042d7765677",
  "productndc": "67457-529",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "203800",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "May 19, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 200MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "May 19, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 350MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "May 19, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEUCOVORIN CALCIUM",
  "proprietary_name": "LEUCOVORIN CALCIUM",
  "active_ingred_unit": "mg/20mL",
  "application_number": "ANDA203800",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LEUCOVORIN CALCIUM",
  "start_marketing_date": "20190723",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code V03AF03.

Access this data programmatically

Query LEUCOVORIN CALCIUM and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs