Norco 325 mg/1
Hydrocodone/APAP · TABLET · Direct_Rx
Norco is a prescription tablet containing hydrocodone (an opioid pain reliever) and acetaminophen (a pain reliever and fever reducer) used to treat moderate pain. It is taken by mouth and is available in a 325 mg/10 mg formulation.
Key Facts
- Brand Name
- Norco
- Generic Name
- Hydrocodone/APAP
- NDC Code (Product)
72189-399- Manufacturer
- Direct_Rx
- Strength
- 325 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA040400
- Marketing Start
- 11/23/2022
Recall History
ALLERGAN
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Full Prescribing Information
Indications & Usage
Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia
Dosage & Administration
Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse (see WARNINGS). Follow patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with hydrocodone bitartrate and acetaminophen tablets and adjust the dosage accordingly (see WARNINGS). Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with hydrocodone bitartrate and acetaminophen tablets (see WARNINGS, LIFE-THREATENING RESPIRATORY DEPRESSION; PRECAUTIONS, INFORMATION FOR PATIENTS). Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual stat…
Warnings
Addiction, Abuse, and Misuse Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a Schedule II controlled substance. As an opioid, hydrocodone bitartrate and acetaminophen tablets expose users to the risks of addiction, abuse, and misuse (see DRUG ABUSE AND DEPENDENCE). Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed hydrocodone bitartrate and acetaminophen tablets. Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing hydrocodone bitartrate and acetaminophen tablets, and monitor all patients receiving hydrocodone bitartrate and acetaminophen tablets for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as hydrocodone bitartrate and acetaminophen tabl…
Contraindications
Hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: Significant respiratory depression (see WARNINGS) Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see WARNINGS) Known or suspected gastrointestinal obstruction, including paralytic ileus (see WARNINGS) Hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) (see WARNINGS and ADVERSE REACTIONS)
Adverse Reactions
The following adverse reactions have been identified during post approval use of hydrocodone bitartrate and acetaminophen tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. Other adverse reactions include: Central Nervous System – Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychological dependence, mood changes. Gastrointestinal System – Constipation. Genitourinary System – Ureteral spasm, spasm of vesical sphincters, and urinary retention. Special Senses – Cases of hearing impairment, or permanent loss have been reported predominantly in patients with chronic overdose. Dermatological – Skin rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions. Hematological – Thrombocytopenia, agranulocytosis. Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during con…
Frequently Asked Questions
What is Norco used for?
Norco is a prescription tablet containing hydrocodone (an opioid pain reliever) and acetaminophen (a pain reliever and fever reducer) used to treat moderate pain. It is taken by mouth and is available in a 325 mg/10 mg formulation.
Is Norco a controlled substance?
Yes, Norco is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Norco?
The generic name for Norco is Hydrocodone/APAP. There are 4 other brand versions of Hydrocodone/APAP.
What is the NDC code for Norco 325 mg/1?
The NDC (National Drug Code) for Norco 325 mg/1 is 72189-399, listed by Direct_Rx.