New Drug Application Filed for Generic Hydrocodone Combination

Officials with Elite Pharmaceuticals have filed an abbreviated new drug application with the FDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets) in doses of 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg. The medication is typically used to relieve moderate-to-severe pain.

“Hydrocodone/acetaminophen is a strategic addition to Elite’s pain medicine portfolio. This immediate release opioid product is used extensively by doctors today in pain management,” Nasrat Hakim, president and CEO of Elite, said in a press release. “The acetaminophen creates irritation if the product is crushed and taken intranasally, thereby potentially providing some intranasal abuse-deterrence according to the FDA.”

Norco is not recommended for individuals who may be allergic to acetaminophen or hydrocodone. Patients should also consider the effects of the medication if they have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Hydrocodone may be habit-forming for some individuals, even at a regular dose. Patients should follow all of the information on their prescription level and inform their doctor of their pain as they take the drug.

The most common adverse effects associated with Norco are dizziness and lightheadedness. In general, acetaminophen and hydrocodone may cause drowsiness, sleepiness, and a relaxed or calming sensation.