Leucovorin Calcium

Orange BookUNIISPLATC V03AF03

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

Identification

ManufacturerIngenus Pharmaceuticals, LLC

CountryUS (United States)

ATC codeV03AF03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5074218212
12 TABLET in 1 BOTTLE (50742-182-12)
ndc11
5074218224
24 TABLET in 1 BOTTLE (50742-182-24)

Annotations

UNII (FDA Substance ID)

RPR1R4C0P4

LEUCOVORIN CALCIUM

RxCUI 225852

Orange Book

A211132

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": "50742-182_93e939b7-2201-442a-a2be-7c5804f8be6f",
  "productndc": "50742-182",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211132",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Jul 30, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Jul 30, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 15MG BASE",
        "product_no": "003",
        "approval_date": "Jul 30, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "004",
        "approval_date": "Jul 30, 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": "ANDA211132",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Leucovorin Calcium",
  "start_marketing_date": "20200730",
  "active_numerator_strength": "10"
}

Related drugs

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