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.

FDA Label Image

600 mg-500s (600 mg 500s)

Label for Gabapentin Tablets, USP 600 mg by Camber Pharmaceuticals, Inc. The label indicates a package of 500 oral tablets, Rx only. It includes storage instructions, dosage and use guidance, and manufacturing information for Ascent Pharmaceuticals, Inc. and Camber Pharmaceuticals, Inc. The label features the lot and expiration fields and a barcode.*

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600 mg-100s (600mg 100s)

GABAPENTIN 600 mg Tablets, USP label from Camber Pharmaceuticals, Inc. The label includes the NDC 31722-166-01, indicates the package contains 100 oral tablets, and notes storage instructions and dispensing information. The strength is prominently displayed as 600 mg, and the label specifies prescription use only.*

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800 mg-100s (800 mg 100s)

Label for Gabapentin Tablets, USP 800 mg by Camber Pharmaceuticals, Inc. The label shows the product name, dosage strength of 800 mg, quantity of 100 tablets, and prescription-only status. Storage instructions specify 25°C with permitted excursions. Manufacturer information for Ascent Pharmaceuticals and Camber Pharmaceuticals is included.*

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800 mg-500s (800 mg 500s)

Label for Gabapentin Tablets, USP 800 mg by Camber Pharmaceuticals, Inc. The label shows the product name, strength (800 mg), and a quantity of 500 tablets. It includes storage instructions, dosage and use directions referencing a package insert, manufacturing and distribution information, and a note for pharmacists to dispense a medication guide with the product.*

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Sideeffects (Sideeffects)

A bulleted list of potential side effects or symptoms, 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 showing Gabapentin dosage recommendations based on renal function, measured by creatinine clearance (mL/min). It includes total daily dose ranges (mg/day) and specific dose regimens (mg) for different renal clearance levels, along with supplemental doses for patients undergoing hemodialysis. The table provides guidance for dose adjustments in patients with varying degrees of renal impairment.*

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Table-2 (Table2)

A data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' presenting risk statistics for placebo and drug patients across indications such as Epilepsy, Psychiatric, and Other. Columns include events per 1,000 patients for placebo and drug groups, relative risk, and risk difference for additional drug patients with events.*

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Table-3 (Table3)

A data table titled 'Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' comparing the percentage of adverse reactions reported for Gabapentin (N=336) versus Placebo (N=227). The table categorizes reactions by body system, including Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses, listing various specific adverse reactions and their corresponding percentages for each group.*

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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 percentage of adverse events between Gabapentin (N=543) and placebo (N=378) groups. The table categorizes events by body system, listing specific adverse reactions such as fatigue, somnolence, dizziness, and diplopia with their corresponding incidence percentages for each group.*

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Table-5 (Table5)

A data table titled 'TABLE 5. Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years' lists adverse reactions by body system for Gabapentin (N=119) compared with placebo (N=128). It includes percentages of reactions such as viral infection, fever, increased weight, fatigue, nausea/vomiting, somnolence, hostility, emotional lability, dizziness, hyperkinesia, bronchitis, and respiratory infection.*

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Table-6 (Table6)

A table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' showing study duration in weeks, gabapentin target dose in mg/day, and number of patients receiving gabapentin or placebo across two studies, with totals provided. Gabapentin doses are given in three divided doses (TID).*

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Clcr (Clcr)

An equation illustrating the calculation of creatinine clearance (CLCr). The formula includes age in years, weight in kg, serum creatinine in mg/dL, and a multiplication factor of 0.85 for female patients.*

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Figure-1 (Figure1)

A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 1' comparing placebo and gabapentin 3600 mg/day over 8 weeks. The x-axis represents weeks from baseline to week 8, and the y-axis shows mean pain scores from 0 to 10. The data illustrate a decreasing pain score trend for gabapentin, while placebo remains relatively constant.*

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Figure-2 (Figure2)

A line graph showing weekly mean pain scores for placebo and two doses of Gabapentin (1800 mg/day and 2400 mg/day) over a 7-week study period. The graph includes a 3-week dose titration period followed by a 4-week fixed dose period. Pain scores decrease more with Gabapentin compared to placebo.*

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Figure-3 (Figure3)

Bar chart showing the proportion of responders (patients with 50% or greater reduction in pain score) at the endpoint in two controlled PHN (postherpetic neuralgia) studies. The chart compares placebo (PBO) groups with Gabapentin (GBP) groups at 3600 mg, 1800 mg, and 2400 mg doses, indicating statistically significant higher response rates in Gabapentin groups versus placebo.*

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Figure-4 (Figure4)

A scatter plot showing the responder rate difference (%) from placebo by daily dose (mg) for Gabapentin in adjunctive therapy studies with patients aged 12 years and older with partial seizures. The chart compares results from three studies (a, b, c) across doses ranging from 600 to 1800 mg.*

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Struc (Struct)

Chemical structure of gabapentin showing its cyclohexane ring with attached amino and carboxyl functional groups.*

* 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.