United States· US:68083-279_c3b9daf5-c553-46af-b651-841b43b2e706

levoleucovorin

A medicinal product containing levoleucovorin calcium, registered in United States by Gland Pharma Limited.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedlevoleucovorinATC—REGISTER NO.US:68083-279_c3b9daf5…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
LEVOLEUCOVORIN CALCIUM
Manufacturer
Gland Pharma Limited
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    6808327901
    1 VIAL in 1 CARTON (68083-279-01) / 25 mL in 1 VIAL
  • ndc11
    68083-279-01

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Levoleucovorin calcium in 9 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All levoleucovorin calcium products

Authorised across Europe · EMA

The same active substance is authorised in 18 EEA countries. Names it is sold under:

  • Austria · Voxsio
  • Belgium · Elvorine, Levofolic
  • Germany · Levofolic, Voxsio
  • Estonia · Levofolinic Acid Medac
  • Spain · Isovorin
  • Finland · Levofolic
  • France · Elvorine, Levofolinate De Calcium Zentiva
  • United Kingdom (Northern Ireland) · Levofolinic Acid Medac
  • Greece · Folivoran
  • Italy · Calcio Levofolinato Teva Generics, Folanemin
  • Lithuania · Levofolino Rugštis Medac
  • Luxembourg · Elvorine
  • Latvia · Levofolic
  • Poland · Levofolic
  • Portugal · Levofolic, Levofolinato De Cálcio Farmoz
  • Sweden · Natriumlevofolinat Medac
  • Slovenia · Levofolic
  • Slovakia · Levofolic

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/e33793bd-6a01-40b4-86e2-14b5514eaa78
GET /v1/drugs/e33793bd-6a01-40b4-86e2-14b5514eaa78?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "INTRAVENOUS",
  "source": "ndc",
  "strength": "10",
  "substance": "LEVOLEUCOVORIN CALCIUM",
  "productndc": "68083-279",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA210892",
  "marketing_category": "ANDA"
}

See everything about levoleucovorin calcium.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.