Source: FDA, National Drug Code (US) Revision Year: 2022
ULTRACET (tramadol hydrochloride/acetaminophen) Tablets combines two analgesics, tramadol hydrochloride and opioid agonist, and acetaminophen.
The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]1(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:
The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline, and odorless powder.
The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is:
The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste.
ULTRACET tablets contain 37.5 mg of tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are carnauba wax, corn starch, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized corn starch, sodium starch glycolate, and titanium dioxide.
Meets USP Dissolution Test 2.
| Dosage Forms and Strengths |
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ULTRACET tablets each contain 37.5 mg of tramadol hydrochloride and 325 mg of acetaminophen. The tablets are light yellow, coated, capsule-shaped, and debossed with “O-M” on one side and “650” on the other. |
| How Supplied | ||||||
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ULTRACET (tramadol hydrochloride/acetaminophen) tablets containing 37.5 mg tramadol hydrochloride and 325 mg acetaminophen are light yellow, coated, capsule-shaped tablets debossed with “O-M” on one side and “650” on the other and are available as follows:
Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, USA |
| Drug | Countries | |
|---|---|---|
| ULTRACET | Brazil, Hong Kong, Singapore, United States, South Africa |
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