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Active ingredient

Leucovorin

63 finished FDA listings contain Leucovorin as their only active ingredient; 2 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
LEUCOVORIN, LEUCOVORIN CALCIUM
Dosage forms
Injection, Injection, Powder, Lyophilized, For Solution, Injection, Powder, Lyophilized, For Suspension, Tablet
Routes
Intramuscular, Intravenous, Oral
Manufacturers / labelers
19
Strengths listed
10 mg/1 · 10 mg/ml · 100 mg/1 · 100 mg/10ml · 15 mg/1 · 200 mg/1 · 200 mg/20ml · 25 mg/1 · 350 mg/1 · 350 mg/17.5ml · 350 mg/35ml · 5 mg/1 · 50 mg/1 · 50 mg/5ml · 500 mg/1 · 500 mg/50ml
Brand names in FDA listings
Lederle Leucovorin, Vykoura

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6313

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 089384HIKMA1987-09-141
ANDA 071199BARR1987-09-242
ANDA 071198BARR1987-09-241
ANDA 089717HIKMA1988-03-282
ANDA 072736HIKMA1993-02-221
ANDA 072735HIKMA1993-02-221
ANDA 072734HIKMA1993-02-221
ANDA 072733HIKMA1993-02-222
ANDA 040056HIKMA1995-05-233
ANDA 074544EPIC PHARMA LLC1997-08-284
ANDA 040258FRESENIUS KABI USA1999-02-262
ANDA 040286FRESENIUS KABI USA1999-02-261
ANDA 040335HIKMA2000-04-202
ANDA 200855SAGENT PHARMS2012-09-061
ANDA 200753SAGENT PHARMS2012-09-063
ANDA 203800MYLAN LABS LTD2017-05-193
ANDA 209110SAGENT PHARMS INC2017-10-261
ANDA 207241FRESENIUS KABI USA2018-03-141
ANDA 207226FRESENIUS KABI USA2018-07-271
ANDA 211132INGENUS PHARMS LLC2020-07-305
ANDA 213929LEADING2020-10-225
ANDA 217021HAINAN POLY2023-07-105
ANDA 216590MEITHEAL2023-07-198
ANDA 218200GLAND2025-11-122
NDA 220406AVYXA HOLDINGS2026-02-033

Official labeling on DailyMed

Showing the 12 most recent of 26 labels.

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