Gabapentin Capsule
Product Images NDC 31722-148

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 31722-148). 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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100 mg (100mg 1000count)

Label for Gabapentin Capsules USP 100 mg by Camber Pharmaceuticals, Inc. The label displays the NDC number 31722-148-10 and indicates a package size of 1000 capsules. It includes storage instructions, dispensing requirements, and directions to consult the package insert for dosage and use information.*

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100 mg (100mg 100counts)

Label for Gabapentin Capsules, USP 100 mg by Camber Pharmaceuticals, Inc. The label shows the NDC 31722-148-01 and indicates a package of 100 capsules. It includes storage instructions, dosing information reference, and manufacturer details for Ascent Pharmaceuticals, Inc. and Camber Pharmaceuticals, Inc.*

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100 mg (100mg 500count)

Gabapentin Capsules, USP 100 mg oral capsules in a 500-count container. The label includes the NDC 31722-148-05 and states the product is manufactured by Ascent Pharmaceuticals, Inc., and labeled by Camber Pharmaceuticals, Inc. Storage instructions are for 25°C with excursions permitted between 15° to 30°C. The label instructs pharmacists to dispense the Medication Guide separately and notes Rx-only status.*

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300 mg (300mg 100count)

Label for Gabapentin Capsules, USP 300 mg by Camber Pharmaceuticals, Inc. The label indicates the product comes in a 100 capsule bottle, is prescription only, and includes storage instructions and manufacturer information. The label prominently displays the active ingredient strength (300 mg) and the NDC number 31722-149-01.*

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300 mg (300mg 500count)

Label for Gabapentin Capsules, USP 300 mg by Camber Pharmaceuticals, Inc. The label indicates a package of 500 capsules, with storage instructions, dosage and use information referencing the package insert, and manufacturer details for Ascent Pharmaceuticals, Inc. and Camber Pharmaceuticals, Inc.*

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400 mg (400mg 100count)

Label for Gabapentin Capsules, USP 400 mg by Camber Pharmaceuticals, Inc. The label states this is a prescription drug available in a bottle of 100 capsules. It includes storage instructions, dispensing guidance, manufacturer info (Ascent Pharmaceuticals, Inc.), and a note to provide the Medication Guide separately to each patient.*

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400 mg (400mg 500count)

The label of Gabapentin Capsules, USP 400 mg by Camber Pharmaceuticals, Inc. It includes the NDC 31722-150-05 and indicates the package contains 500 capsules. Storage instructions specify 25°C with permitted excursions. The label advises dispensing with the Medication Guide and provides manufacturing information for Ascent Pharmaceuticals and Camber Pharmaceuticals.*

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Equation (Equ)

An equation displaying the formula for calculating creatinine clearance (CLCr), including variables for age in years, weight in kilograms, serum creatinine in mg/dL, and an adjustment factor for female patients (0.85). This formula is clinical and pharmacological in nature, shown as text in the image.*

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Fig 1 (Fig 1)

A line graph depicting weekly mean pain scores over an 8-week period comparing placebo and gabapentin 3600 mg/day treatments. The x-axis represents weeks, while the y-axis shows the mean pain score. Gabapentin shows a decreasing trend in pain scores compared to placebo.*

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Fig 2 (Fig 2)

A line graph showing weekly mean pain scores over 7 weeks from a clinical study. The x-axis represents weeks, including baseline, weeks 1 to 7, and the y-axis represents mean pain scores from 0 to 10. Three groups are plotted: placebo, gabapentin 1800 mg/day, and gabapentin 2400 mg/day, showing pain score trends over time.*

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Fig 3 (Fig 3)

A bar chart titled "Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies". It compares the percentage of responders for placebo (PBO) and gabapentin (GBP) at different dosages across two studies. Study 1 shows 12% for placebo and 29% for GBP 3600 mg. Study 2 shows 14% for placebo, 32% for GBP 1800 mg, and 34% for GBP 2400 mg. Statistical significance is indicated for gabapentin doses.*

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Fig 4 (Fig 4)

A scatter plot chart showing responder rate differences (%) from placebo by daily gabapentin dose (mg) across three studies labeled a, b, and c. The x-axis represents daily dose from 600 to 1800 mg, and the y-axis shows difference percentages from 2% to 22%. Study a is represented by black squares, study b by gray squares, and study c by white squares, with data points indicating variability in response rates at different dose levels.*

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Structure (Struct)

Chemical structure diagram of gabapentin showing a cyclohexane ring bonded to an amino group and a carboxymethyl group, representing the molecular structure of the active ingredient gabapentin.*

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Table 1 (Tab 1)

A table titled 'Gabapentin Dosage Based on Renal Function' outlining dosing guidelines according to renal function measured by creatinine clearance (mL/min). It includes columns for total daily dose range (mg/day), dose regimen in mg with frequencies for various dosing schedules (QD, BID, TID), and a section for post-hemodialysis supplemental doses (mg). Additional footnotes provide details on dose adjustments for low creatinine clearance and hemodialysis patients.*

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Table 2 (Tab 2)

A data table titled 'Risk by Indication for Antiepileptic Drugs in the Pooled Analysis,' presenting the incidence of events per 1,000 patients among placebo and drug patients for epilepsy, psychiatric, and other indications. It includes columns for relative risk and risk difference for additional drug events compared to placebo.*

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Table 3 (Tab 3)

Data table titled 'Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' comparing the incidence percentages of various adverse reactions between gabapentin (N=336) and placebo (N=227). Reactions are categorized by body system including Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses. The table lists specific reactions such as asthenia, diarrhea, dizziness, somnolence, and amblyopia with their corresponding incidence percentages for each group.*

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Table 4 (Tab 4)

A data table titled 'TABLE 4. Adverse Reactions in Pooled Placebo-Controlled Add-On Trials In Epilepsy Patients >12 years of age' comparing the percentage of various adverse reactions reported for gabapentin (N=543) versus placebo (N=378). The table lists reactions grouped by body system including Body As A Whole, Cardiovascular, Digestive System, Nervous System, Respiratory System, Skin and Appendages, Urogenital System, and Special Senses.*

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Table 5 (Tab 5)

A table presenting adverse reactions in a placebo-controlled add-on trial in pediatric epilepsy patients aged 3 to 12 years, comparing gabapentin (N=119) and placebo (N=128). The table lists percentages for side effects across body systems including Body As A Whole, Digestive System, Nervous System, and Respiratory System.*

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Tab 6 (Tab 6)

A data table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' summarizing two studies with durations of 8 and 7 weeks, target gabapentin doses in mg/day, and patient counts receiving gabapentin and placebo. The table presents gabapentin doses of 3600 mg/day for study 1 and 1800 and 2400 mg/day for study 2, alongside the numbers of patients in each treatment group.*

* 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.