SPL Set ID: 39219e4b-80a6-4d4f-96a3-1202e542d050

1 drug(s) with this SPL Set ID

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Pemetrexed PEMETREXED DISODIUM
SOMERSET THERAPEUTICS LLC FDA Rx Only

Pemetrexed for injection USP is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium hemi- pentahydrate, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4- oxo-1H-pyrrolo[2,3-d] pyrimidin-5yl) ethyl] benzoyl]-, Disodium, hemi-pentahydrate with a molecular formula of C 20 H 19 N 5 Na 2 O 6 2.5 H 2 O and a molecular weight of 516.37. The structural formula is as follows: Pemetrexed for injection USP is a sterile white-to-light yellow or green-yellow lyophilized powder in single-dose vials to be reconstituted for intravenous infusion. Each 100-mg vial of pemetrexed for injection USP contains 100 mg pemetrexed (equivalent to 110.3 mg pemetrexed disodium hemi- pentahydrate) and 106 mg mannitol. Each 500 mg vial of pemetrexed for injection USP contains 500 mg pemetrexed (equivalent to 551.4 mg pemetrexed disodium hemi- pentahydrate) and 500 mg mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH. Structural Formula

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