Source: FDA, National Drug Code (US) Revision Year: 2021
Oxymorphone hydrochloride tablets are an opioid agonist available in 5 mg and 10 mg tablet strengths for oral administration. The chemical name for oxymorphone hydrochloride is 4, 5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 337.80.
The molecular formula is C17H19NO4•HCl and it has the following chemical structure.
Oxymorphone hydrochloride is white or slightly off-white odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water.
The inactive ingredients in oxymorphone hydrochloride tablets include: lactose monohydrate, magnesium stearate, and pregelatinized maize starch. In addition, the 5 mg tablets contain FD&C blue No. 2 aluminum lake. The 10 mg tablets contain D&C red No. 30 aluminum lake.
| Dosage Forms and Strengths |
|---|
|
Tablets 5 mg: blue, round, biconvex tablet debossed with “K” above “70” on one side and plain on the other. Tablets 10 mg: red, round, biconvex tablet debossed with “K” above “71” on one side and plain on the other. |
| How Supplied |
|---|
|
Oxymorphone hydrochloride tablets are supplied as follows: 5 mg Tablet: Blue, round, biconvex tablets debossed with “K” above “70” on one side and plain on the other. Bottles of 60 tablets with child-resistant closure NDC 10702-070-06 Bottles of 100 tablets with child-resistant closure NDC 10702-070-01 10 mg Tablet: Red, round, biconvex tablets debossed with “K” above “71” on one side and plain on the other. Bottles of 60 tablets with child-resistant closure NDC 10702-071-06 Bottles of 100 tablets with child-resistant closure NDC 10702-071-01 Manufactured by: KVK-Tech, Inc., 110 Terry Drive, Newtown, PA 18940 |
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