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Active ingredient

Pemetrexed

74 finished FDA listings contain Pemetrexed as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
PEMETREXED, PEMETREXED DISODIUM, PEMETREXED DISODIUM HEMIPENTAHYDRATE, PEMETREXED DISODIUM HEPTAHYDRATE, PEMETREXED MONOHYDRATE
Dosage forms
Injection, Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Injection, Solution, Injection, Solution, Concentrate, Solution, Concentrate
Routes
Intravenous
Manufacturers / labelers
24
Strengths listed
1 g/40ml · 100 mg/1 · 100 mg/10ml · 100 mg/4.2ml · 100 mg/4ml · 1000 mg/100ml · 1000 mg/40ml · 25 mg/ml · 500 mg/20ml · 500 mg/50ml · 750 mg/30ml
Brand names in FDA listings
Alimta, Axtle, Pemetrexed, Pemfexy, Pemrydi Rtu

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 68446

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
NDA 021462LILLY2004-02-042
NDA 209472EAGLE PHARMS2020-02-082
NDA 208419ACTAVIS2020-08-213
ANDA 214632EUGIA PHARMA2022-05-255
ANDA 211899RELIANCE LIFE2022-05-254
ANDA 090384FRESENIUS KABI USA2022-05-254
ANDA 209851APOTEX2022-05-251
ANDA 204890QILU PHARM HAINAN2022-05-256
ANDA 208696JIANGSU HANSOH PHARM2022-05-256
ANDA 202596DR REDDYS2022-05-253
ANDA 203485ACCORD HLTHCARE2022-05-253
ANDA 203774APOTEX2022-05-252
ANDA 209085APOTEX2022-05-251
ANDA 214073ZYDUS PHARMS2022-05-256
NDA 214657SANDOZ2022-05-263
NDA 214218HOSPIRA2022-06-226
ANDA 215479MEITHEAL2022-12-134
NDA 215179SHILPA2023-05-226
ANDA 216582PRINSTON INC2023-12-111
ANDA 215460HETERO LABS LTD VI2024-06-142
NDA 210661AVYXA HOLDINGS2024-06-284

Official labeling on DailyMed

Showing the 12 most recent of 31 labels.

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