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United States · US · US:68001-416_d5ee26ca-d963-687f-e053-2a95a90a2a50

Leucovorin Calcium

Orange BookUNIISPLATC V03AF03

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

Identification

ManufacturerBluePoint Laboratories
CountryUS (United States)
ATC codeV03AF03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6800141636
    1 VIAL in 1 BOX (68001-416-36) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
RPR1R4C0P4
LEUCOVORIN CALCIUM
RxCUI 225852
Orange Book
A089717
AP
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": "68001-416_d5ee26ca-d963-687f-e053-2a95a90a2a50",
  "productndc": "68001-416",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "089717",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Mar 28, 1988"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEUCOVORIN CALCIUM",
  "proprietary_name": "Leucovorin Calcium",
  "active_ingred_unit": "mg/10mL",
  "application_number": "ANDA089717",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Leucovorin Calcium",
  "start_marketing_date": "20190926",
  "active_numerator_strength": "100"
}

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