Gabapentin Tablet
Product Images NDC 31722-166

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 31722-166). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Camber Pharmaceuticals, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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600 mg-500s (600 mg 500s)

This is a description of Gabapentin Tablets, USP, containing 500 tablets of 600 mg each. The medication guide is available online, and should be dispensed separately to each patient by the pharmacist. The tablets must be stored at a controlled temperature between 15° to 30°C (59° to 86°F). The dosage and other information regarding the medication should be obtained from the package insert. The tablets have been manufactured by Astent Pharmaceutical and distributed by Camber Pharmaceuticals, Inc., Piscataway, NJ 08854.*

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600 mg-100s (600mg 100s)

This is a description for medication named Gabapentin Tablets. The package contains 100 tablets of 600 mg USP. It must be stored between 15°C to 30°C. The medication guide should be provided to each patient. The pharmacist should dispense it in tight (USP), child-resistant containers. For detailed information, see the package insert. It is manufactured by Ascent Pharmaceuticals, Inc., based in Centrallslp, NY, 11722, and is manufactured for Camber Pharmaceuticals, Inc., based in Piscataway, NJ, 08854.*

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800 mg-100s (800 mg 100s)

This is a description for Gabapentin tablets, USP. The medication is dispensed with a medication guide to each patient. The tablets should be stored at room temperature and dispensed in tight, child-resistant containers. The dosage and use information can be found in the package insert. The medication is manufactured by Ascent Pharmaceuticals and distributed by Camber Pharmaceuticals.*

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800 mg-500s (800 mg 500s)

This is a label for a bottle of gabapentin tablets, USP with 800 mg gabapentin in each tablet. It contains information about dosage, use, storage, and manufacturer details. It also mentions the availability of a medication guide for patients.*

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Sideeffects (Sideeffects)

This text describes possible symptoms that a person may experience. These symptoms can be related to different health conditions, such as viral infections or neurological disorders. Some of the symptoms mentioned are difficulty with speech, tremors, swelling, fatigue, fever, drowsiness, nausea and vomiting. Additionally, there may be coordination and movement difficulties, as well as double vision and unusual eye movements. It is important to consult a medical professional for proper diagnosis and treatment.*

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Table-1 (Table1)

This is a table providing dosages of Gabapentin based on renal function. The table lists various creatinine clearance ranges with corresponding dosage regimens. The dosage regimen includes the total daily dose in milligrams, along with the frequency of medication intake (TID, BID, or QD). A supplemental post-hemodialysis dose is also provided for patients on hemodialysis. The table also notes that for patients with creatinine clearance less than 15 mL/min, the daily dose should be reduced in proportion to creatinine clearance.*

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Table-2 (Table2)

This text presents a table showing the risk by indication for antiepileptic drugs in a pooled analysis. The indications are categorized into three groups: epilepsy, psychiatric, and other, with corresponding total numbers. The table compares placebo patients to drug patients and provides the incidence per 1,000 patients for each group, as well as the relative risk and risk difference. No further context or explanation is given.*

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Table-3 (Table3)

This is a table showing the adverse reactions in pooled placebo-controlled trials in postherpetic neuralgia for gabapentin and placebo. The table lists the number of patients (N) and the percentage (%) of adverse reactions for each system of the body. Adverse reactions that occurred more frequently in the gabapentin group compared to the placebo group include dizziness, somnolence, peripheral edema, diarrhea, dry mouth, and constipation. Gabapentin is also associated with blurred vision. Some adverse reactions that occurred more frequently in the placebo group include accidental injury, and infection. There were no adverse reactions reported for weight gain and hyperglycemia in the placebo group.*

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Table-4 (Table4)

This is a table containing adverse reactions in pooled placebo-controlled add-on trials in epilepsy patients above 12 years of age who were given Gabapentin or a Placebo. The table shows the percentage of patients who experienced each adverse reaction. Adverse reactions reported included fatigue, increased weight, back pain, peripheral edema, cardiovascular reactions, digestive system issues, nervous system issues, depression, abnormal thinking, respiratory system issues, abrasion, urogenital system issues, special senses issues and more. Amblyopia, which is often described as blurred vision was reported in patients who received Gabapentin.*

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Table-5 (Table5)

This is a table showing adverse reactions in a placebo-controlled add-on trial for pediatric epilepsy patients aged 3 to 12 years who were treated with Gabapentin compared to Placebo. The adverse reactions are listed as "Nausea and/or Vomiting", "Emotional Lability", "Respiratory Infection" and "Phos b rooml mtepilepii drag ey". The last adverse reaction appears to be a misread error and is not understandable.*

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Table-6 (Table6)

This is a table showing the duration, dosages, and number of patients in two controlled studies analyzing the use of Gabapentin for PHN. Study 1 lasted 8 weeks with a target dose of 3600mg/day and had 113 patients receiving Gabapentin and 116 receiving placebo. Study 2 lasted 7 weeks, with target doses of either 1800mg/day or 2400mg/day given in three divided doses and had 223 patients receiving Gabapentin and 111 receiving placebo. The total number of patients in both studies was 336 in the Gabapentin group and 221 in the Placebo group.*

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Clcr (Clcr)

This is a medical formula that calculates the estimated glomerular filtration rate (eGFR) using the serum creatinine level, age, weight, and gender of the patient. It is specifically targeting female patients by using a coefficient of 0.65. Not much else can be inferred from the text.*

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Figure-1 (Figure1)

This appears to be a graph displaying weekly mean pain scores in a study population (ITT Population) relating to the observed cases. The graph shows the pain scores based on the baseline and each subsequent week up to week 8. The medication given appears to be Gabapentin at a dose of 3500 iy.*

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Figure-2 (Figure2)

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Figure-3 (Figure3)

The text describes a figure (Figure 3) that shows the proportion of patients who experienced a reduction in pain score of >50% at the end of controlled PHN studies. The figure includes data from Study 1 and Study 2, comparing a placebo group with two groups receiving different doses of GBP (1800 and 2400). However, the output contains some errors and missing information.*

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Figure-4 (Figure4)

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Struc (Struct)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.