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Active ingredient

Levoleucovorin

13 finished FDA listings contain Levoleucovorin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
LEVOLEUCOVORIN, LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN DISODIUM
Dosage forms
Injection, Injection, Powder, Lyophilized, For Solution, Injection, Solution
Routes
Intravenous
Manufacturers / labelers
9
Strengths listed
10 mg/1 · 10 mg/ml · 175 mg/17.5ml · 175 mg/3.5ml · 250 mg/25ml · 50 mg/5ml
Brand names in FDA listings
Khapzory, Levoleucovorin, Levoleucovorin Calcium

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 877015

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 206263HIKMA2016-06-161
ANDA 207548AMNEAL2017-09-081
ANDA 210892GLAND2018-09-144
NDA 211226ACROTECH BIOPHARMA2018-10-191
ANDA 211002MEITHEAL2019-08-161
ANDA 211003MEITHEAL2019-08-221
ANDA 217314HAINAN POLY PHARM2023-05-224

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.