Leucovorin Calcium

Orange BookUNIISPLATC V03AF03

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

Identification

ManufacturerEpic Pharma LLC

CountryUS (United States)

ATC codeV03AF03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4280613321
12 TABLET in 1 BOTTLE (42806-133-21)
ndc11
4280613324
24 TABLET in 1 BOTTLE (42806-133-24)

Annotations

UNII (FDA Substance ID)

RPR1R4C0P4

LEUCOVORIN CALCIUM

RxCUI 225852

Orange Book

A074544

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": "42806-133_9db189e6-7ecc-465c-8197-c454350a45dc",
  "productndc": "42806-133",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "074544",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 28, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Aug 28, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "May 19, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 15MG BASE",
        "product_no": "004",
        "approval_date": "May 19, 2021"
      }
    ],
    "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": "ANDA074544",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Leucovorin Calcium",
  "start_marketing_date": "20210101",
  "active_numerator_strength": "10"
}

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