Tramadol/APAP 325 mg/1
Tramadol/APAP · TABLET · Direct_rx
Tramadol/Acetaminophen is a prescription tablet that combines an opioid pain reliever with acetaminophen to treat moderate pain. It is taken by mouth and should be used exactly as prescribed by your doctor.
Key Facts
- Brand Name
- Tramadol/APAP
- Generic Name
- Tramadol/APAP
- NDC Code (Product)
72189-671- Manufacturer
- Direct_rx
- Strength
- 325 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA090485
- Marketing Start
- 03/30/2026
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride 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. Tramadol hydrochloride and acetaminophen tablets should not be used for an extended period of time.
Dosage & Administration
2.1 Important Dosage and Administration Instructions Tramadol hydrochloride and acetaminophen tablets are not approved for use for more than 5 days. Do not exceed the recommended dose of tramadol hydrochloride and acetaminophen tablets. Do not co-administer tramadol hydrochloride and acetaminophen tablets with other tramadol or acetaminophen containing products [see Warnings and Precautions (5.20)]. Tramadol hydrochloride and acetaminophen tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5)]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of tramadol hydrochloride and acetaminophen tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require …
Contraindications
Tramadol hydrochloride and acetaminophen tablets are contraindicated for: all children younger than 12 years of age [see Warnings and Precautions (5.6)] post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.6)]. Tramadol hydrochloride and acetaminophen tablets are also contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2)]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.13)]. Patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.18)]. Previous hypersensitivity to tramadol, acetaminophen, any other component of this product, or opioids [see Warnings and Precautions (5.19)]. Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days [see Drug Interactions (7)].
Drug Interactions
Table 2 includes clinically significant interactions with tramadol hydrochloride and acetaminophen. Table 2: Clinically Significant Drug Interactions with Tramadol Hydrochloride and Acetaminophen Inhibitors of CYP2D6 Clinical Impact: The concomitant use of tramadol hydrochloride and acetaminophen and CYP2D6 inhibitors may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1, particularly when an inhibitor is added after a stable dose of tramadol hydrochloride and acetaminophen is achieved. Since M1 is a more potent μ-opioid agonist, decreased M1 exposure could result in decreased therapeutic effects, and may result in signs and symptoms of opioid withdrawal in patients who had developed physical dependence to tramadol. Increased tramadol exposure can result in increased or prolonged therapeutic effects and increased risk for serious adverse events including seizures and serotonin syndrome. After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease and the M1 plasma concentration will increase which could increase or prolong therapeutic effects but also increase…
Adverse Reactions
The following serious adverse reactions are discussed, or described in greater detail, in other sections: Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.8)] Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children [see Warnings and Precautions (5.6)] Hepatotoxicity [see Warnings and Precautions (5.9)] Serotonin Syndrome [see Warnings and Precautions (5.10)] Seizures [see Warnings and Precautions (5.11)] Suicide [see Warnings and Precautions (5.12)] Adrenal Insufficiency [see Warnings and Precautions (5.14)] Severe Hypotension [see Warnings and Precautions (5.15)] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.18)] Hypersensitivity Reactions [see Warnings and Precautions (5.19)] Withdrawal [see Warnings and Precautions (5.21)] 6.1 Clinical Trials Experience Because clinica…
Frequently Asked Questions
What is Tramadol/APAP used for?
Tramadol/Acetaminophen is a prescription tablet that combines an opioid pain reliever with acetaminophen to treat moderate pain. It is taken by mouth and should be used exactly as prescribed by your doctor.
Is Tramadol/APAP a controlled substance?
Yes, Tramadol/APAP is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Tramadol/APAP?
The generic name for Tramadol/APAP is Tramadol/APAP. There are no other listed brand versions of Tramadol/APAP.
What is the NDC code for Tramadol/APAP 325 mg/1?
The NDC (National Drug Code) for Tramadol/APAP 325 mg/1 is 72189-671, listed by Direct_rx.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)