SPL Set ID: 363665ca-db15-4123-84ac-0ae66b5f1363

1 drug(s) with this SPL Set ID

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pemetrexed PEMETREXED DISODIUM
ZYDUS PHARMACEUTICALS USA INC. FDA Rx Only

Pemetrexed for injection, USP is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium 2.5 hydrate, has the chemical name N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl-L-glutamic acid, disodium salt, dihydrate and hemihydrate with a molecular formula of C 20 H 19 N 5 Na 2 O 6 •2.5H 2 O and a molecular weight of 516.41. The structural formula is as follows: Pemetrexed for injection, USP is a sterile white to either light yellow or green-yellow lyophilized powder or cake 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 110.28 mg pemetrexed disodium) and 106 mg mannitol USP. Each 500-mg vial of pemetrexed for injection, USP contains 500 mg pemetrexed (equivalent to 551.4 mg pemetrexed disodium) and 500 mg mannitol USP. Each 1000-mg vial of pemetrexed for injection, USP contains 1000 mg pemetrexed (equivalent to 1102.8 mg pemetrexed disodium) and 1000 mg mannitol USP. Hydrochloric acid NF and/or sodium hydroxide NF may have been added to adjust pH. Image

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