Source: FDA, National Drug Code (US) Revision Year: 2020
ULTRAM (tramadol hydrochloride) tablets, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis2[(dimethylamino)methyl]1(3-methoxyphenyl) cyclohexanol hydrochloride.
The structural formula is:
The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. ULTRAM tablets contain 50 mg of tramadol hydrochloride (equivalent to 43.9 mg of tramadol) and are white in color. Inactive ingredients in the tablet are pregelatinized corn starch, modified starch (corn), hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and carnauba wax.
| Dosage Forms and Strengths |
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ULTRAM (tramadol hydrochloride) 50 mg tablets are white, capsule-shaped, coated, with a functional score. The tablets are imprinted “ULTRAM” on one side and “06 59” on the scored side. |
| How Supplied |
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ULTRAM (tramadol hydrochloride) 50 mg tablets are white, capsule-shaped, coated, with a functional score. The tablets are imprinted “ULTRAM” on one side and “06 59” on the scored side. Bottle of 100 tablets: NDC 50458-659-60 Manufactured by: Janssen Ortho LLC, Gurabo, Puerto Rico 00778 Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560 |
| Drug | Countries | |
|---|---|---|
| ULTRAM | United States |
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