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United States · US · US:69315-186_f6c54ab5-7d54-4530-955d-206903b9dcad

LEUCOVORIN CALCIUM

Orange BookUNIISPLATC V03AF03

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

Identification

ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeV03AF03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6931518624
    24 TABLET in 1 BOTTLE (69315-186-24)

Annotations

UNII (FDA Substance ID)
RPR1R4C0P4
LEUCOVORIN CALCIUM
RxCUI 225852
Orange Book
A213929
ABABABAB
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": "ORAL",
  "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": "69315-186_f6c54ab5-7d54-4530-955d-206903b9dcad",
  "productndc": "69315-186",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213929",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Oct 22, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Oct 22, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 15MG BASE",
        "product_no": "003",
        "approval_date": "Oct 22, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "004",
        "approval_date": "Oct 22, 2020"
      }
    ],
    "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": "ANDA213929",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LEUCOVORIN CALCIUM",
  "start_marketing_date": "20201116",
  "active_numerator_strength": "15"
}

Related drugs

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