SPL Set ID: 71319a6f-aaf4-4bc5-8b40-a16c6f139be6

1 drug(s) with this SPL Set ID

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Hydrocodone Bitartrate and Homatropine Methylbromide HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
PAI HOLDINGS, LLC DBA PAI PHARMA FDA Rx Only

Hydrocodone bitartrate and homatropine methylbromide oral solution contains hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each spoonful (5 mL) of hydrocodone bitartrate and homatropine methylbromide oral solution contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP, for oral administration. Hydrocodone bitartrate and homatropine methylbromide oral solution also contains: anhydrous citric acid, FD&C Red 40, methylparaben, natural and artificial cherry flavor, propylparaben, purified water, sorbitol solution, sodium citrate dihydrate and sucrose. Hydrocodone Bitartrate The chemical name for hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-,(5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure: Homatropine Methylbromide The chemical name for homatropine methylbromide is 8-Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenyl-acetyl)oxy]-8,8-dimethyl-,bromide, endo-. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure: Structure Structure 2

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