Gabapentin Tablet
Product Images NDC 76282-707

17 FDA label images from Exelan Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 76282-707). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Exelan 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.

FDA Label Image

600 500 Tabs

600 500 Tabs
GABAPENTIN 600 mg oral tablets label from Exelan Pharmaceuticals, Inc. The label indicates the product is for prescription use only, with a package size of 500 tablets. It includes storage instructions and notes that each tablet contains 600 mg of gabapentin. Manufactured by Ascent Pharmaceuticals, Inc. and labeled for Exelan Pharmaceuticals, Inc.*
FDA Label Image

600 90 Tabs

600 90 Tabs
Packaging label for Gabapentin Tablets, USP 600 mg by Exelan Pharmaceuticals, Inc. The label shows NDC 76282-706-90 and indicates a package size of 90 tablets. Storage instructions specify controlled room temperature with excursions permitted between 59° to 86°F. The label includes dispensing guidance and manufacturer details for Ascent Pharmaceuticals, Inc. and Exelan Pharmaceuticals, Inc.*
FDA Label Image

800 500 Tabs

800 500 Tabs
Label for Gabapentin Tablets, USP 800 mg oral tablets, packaged by Exelan Pharmaceuticals, Inc. The label indicates a package size of 500 tablets and includes storage instructions, reference to the medication guide, and manufacturing details identifying Ascent Pharmaceuticals, Inc. as the manufacturer and Exelan Pharmaceuticals, Inc. as the labeler.*
FDA Label Image

800 90 Tabs

800 90 Tabs
Label for Gabapentin Tablets USP 800 mg from Exelan Pharmaceuticals, Inc. The label includes storage instructions, dosage and use notes, and specifies the product contains 90 tablets. It states the product is Rx only and includes the NDC 76282-707-90. Manufacturer and distributor information is also printed.*
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Sideeffects (Sideeffects)

Sideeffects (Sideeffects)
A text panel listing symptoms or side effects related to a drug, including lack of coordination, viral infection, difficulty with speaking, tremor, swelling (usually of legs and feet), feeling tired, fever, feeling drowsy, nausea and vomiting, jerky movements, difficulty with coordination, double vision, and unusual eye movement.*
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Table-1 (Table1)

Table-1 (Table1)
Data table titled 'Gabapentin Dosage Based on Renal Function' showing recommended total daily dose ranges and dose regimens of gabapentin in mg based on renal function measured by creatinine clearance levels. The table includes dosing for various creatinine clearance ranges and specifies post-hemodialysis supplemental doses in mg with notes on dosing frequency (TID, BID, QD) and adjustments for patients with reduced renal function or on hemodialysis.*
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Table-2 (Table2)

Table-2 (Table2)
A data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' listing risk metrics by indication (Epilepsy, Psychiatric, Other, Total). It compares placebo and drug patients with events per 1,000 patients, relative risk, and risk difference for antiepileptic drugs.*
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Table-3 (Table3)

Table-3 (Table3)
A table titled 'Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' comparing the percentages of various adverse reactions between Gabapentin (N=336) and placebo (N=227) groups. The table categorizes reactions by Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses, listing specific side effects such as asthenia, dizziness, and peripheral edema.*
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Table-4 (Table4)

Table-4 (Table4)
A data table titled 'Adverse Reactions in Pooled Placebo-Controlled Add-On Trials in Epilepsy Patients >12 years of age' comparing the frequency percentages of various adverse reactions between Gabapentin (N=543) and placebo (N=378). The table categorizes reactions by body system, including Body As A Whole, Cardiovascular, Digestive System, Nervous System, Respiratory System, Skin and Appendages, Urogenital System, and Special Senses.*
FDA Label Image

Table-5 (Table5)

Table-5 (Table5)
A table listing adverse reactions in a placebo-controlled add-on trial for pediatric epilepsy patients aged 3 to 12 years comparing Gabapentin and placebo groups. It categorizes reactions by body system, including Body As A Whole, Digestive, Nervous, and Respiratory systems, with percentages of patients experiencing each reaction in Gabapentin (N=119) and placebo (N=128) groups.*
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Table-6 (Table6)

Table-6 (Table6)
A table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' showing study number, duration (7-8 weeks), Gabapentin target doses in mg/day, and the number of patients receiving Gabapentin or placebo in each study. It includes totals for patients in both groups.*
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Clcr (Clcr)

Clcr (Clcr)
An illustration showing the formula for calculating creatinine clearance (CLCr) using age, weight, and serum creatinine, including an adjustment factor for female patients. This formula is commonly used in clinical settings to assess kidney function.*
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Figure-1 (Figure1)

Figure-1 (Figure1)
A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 1' showing the mean pain scores over 8 weeks for two groups: placebo and gabapentin 3600 mg/day. The x-axis represents weeks from baseline to week 8, and the y-axis represents mean pain scores from 0 to 10. Gabapentin group's pain scores decrease steadily over time, while placebo group's scores remain relatively constant. The graph also indicates a 4-week dose titration period followed by a 4-week fixed dose period.*
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Figure-2 (Figure2)

Figure-2 (Figure2)
A line chart titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 2' depicting mean pain scores from baseline to week 7. It compares placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day groups over a 3-week dose titration period followed by a 4-week fixed dose period. The y-axis shows mean pain scores from 0 to 10, and the x-axis shows weeks 0 to 7.*
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Figure-3 (Figure3)

Figure-3 (Figure3)
A bar chart titled 'Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies' depicting results from two studies. The chart compares placebo (PBO) and gabapentin (GBP) at various dosages (1800 mg, 2400 mg, 3600 mg) showing the percentage of patients achieving significant pain reduction.*
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Figure-4 (Figure4)

Figure-4 (Figure4)
A scatter plot showing the responder rate difference (%) from placebo in patients receiving Gabapentin by daily dose in mg from three adjunctive therapy studies in patients aged 12 years and older with partial seizures. The x-axis shows daily dose (600, 900, 1200, 1800 mg), and the y-axis shows difference in response rate. Different squares represent Study a, Study b, and Study c data points.*
FDA Label Image

Struc (Struct)

Struc (Struct)
Chemical structure diagram of gabapentin, showing a cyclohexane ring with attached side chains including CH2NH2 and CH2CO2H groups. The structure represents the active ingredient gabapentin used in the GABAPENTIN oral tablet product by Exelan Pharmaceuticals, Inc.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.