Tramadol Hydrochloride 100 mg/1
Tramadol Hydrochloride · TABLET, COATED · Coupler LLC
Tramadol Hydrochloride is a tablet, coated containing tramadol hydrochloride at 100 mg/1, taken oral. Manufactured by Coupler LLC.
Key Facts
- Brand Name
- Tramadol Hydrochloride
- Generic Name
- Tramadol Hydrochloride
- NDC Code (Product)
67046-1541- Manufacturer
- Coupler LLC
- Strength
- 100 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA208708
- Marketing Start
- 03/25/2025
Recall History
The Harvard Drug Group
Packaging defect: blister packaging inadequately sealed.
Amneal Pharmaceuticals, LLC
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Rubicon Research Private Limited
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Golden State Medical Supply Inc.
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
Teva Pharmaceuticals USA
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
Lake Erie Medical & Surgical Supply Inc
Labeling: Incorrect or Missing Lot and/or Exp Date
Caraco Pharmaceutical Laboratories, Ltd.
Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Tramadol hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use • Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosages or duration, and persist over the course of therapy, [see Warnings and Precautions (5.1)], reserve opioid analgesics, including tramadol hydrochloride extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain. • Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. Tramadol hydrochloride extended-release tablets are an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. (1) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Tramadol hydrochloride extended-release tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. (2.1) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of tramadol hydrochloride extended-release 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. (2.1, 5) Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. (2.1, 5.1) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with tramadol hydrochloride extended-release tablets. Consider this risk when selecting an initial dose and when making dose adjustments. (2.1, 5.2) Discuss opioid overdose reversal agents and options for acq…
Contraindications
4 CONTRAINDICATIONS Tramadol hydrochloride extended-release tablets are contraindicated for: all children younger than 12 years of age [see Warnings and Precautions (5.4)] post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.4)] . Tramadol hydrochloride extended-release tablets are also contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.3)] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.12)] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.15)] Hypersensitivity to tramadol (e.g., anaphylaxis) [see Warnings and Precautions (5.17), Adverse Reactions (6.2)] Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days [see Drug Interactions (7)] . Children younger than 12 years of age (4) Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. (4) Significant respiratory depression (4) Acute or severe bronchial asthma i…
Drug Interactions
7 DRUG INTERACTIONS Table 2 includes clinically significant drug interactions with tramadol hydrochloride extended-release tablets. Table 2: Clinically Significant Drug Interactions with Tramadol Hydrochloride Extended-Release Tablets Inhibitors of CYP2D6 Clinical Impact: The concomitant use of tramadol hydrochloride extended-release tablets 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 extended-release tablets 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 incr…
Adverse Reactions
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see Warnings and Precautions (5.6)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)] Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions (5.3)] Opioid-Induced Hyperalgesia and Allodynia [See Warnings and Precautions (5.8)] Serotonin Syndrome [see Warnings and Precautions (5.9)] Seizures [see Warnings and Precautions (5.10)] Suicide [see Warnings and Precautions (5.11)] Adrenal Insufficiency [see Warnings and Precautions (5.13)] Severe Hypotension [see Warnings and Precautions (5.14)] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.16)] Hypersensitivity Reactions [see Warnings and Precautions (5.17)] Withdrawal [see Warnings and Precautions (5.18)] Most common adverse reactions (≥10% and ≥2 x placebo rate): Dizziness…
Frequently Asked Questions
What is Tramadol Hydrochloride used for?
Tramadol Hydrochloride contains Tramadol Hydrochloride. It is a tablet, coated taken oral. Consult your doctor for specific uses.
Is Tramadol Hydrochloride a controlled substance?
Yes, Tramadol Hydrochloride is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Tramadol Hydrochloride?
The generic name for Tramadol Hydrochloride is Tramadol Hydrochloride. There are 10 other brand versions of Tramadol Hydrochloride.
What is the NDC code for Tramadol Hydrochloride 100 mg/1?
The NDC (National Drug Code) for Tramadol Hydrochloride 100 mg/1 is 67046-1541, listed by Coupler LLC.
Other Tramadol Hydrochloride Dosages
Other Tramadol Brands
See all →- TRAMADOL HYDROCHLORIDE300 mg/176420-538
- TRAMADOL HYDROCHLORIDE300 mg/145865-184
- TRAMADOL HYDROCHLORIDE100 mg/147335-531
- TRAMADOL HYDROCHLORIDE300 mg/147335-537
- TRAMADOL HYDROCHLORIDE200 mg/161919-893
- tramadol hydrochloride50 mg/167296-1021
- ConZip100 mg/168025-071
- ConZip200 mg/168025-072
- TRAMADOL HYDROCHLORIDE200 mg/170518-0886
- Tramadol Hydrochloride and Acetaminophen325 mg/171335-1742
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)