Gabapentin Capsule
Product Images NDC 71610-756

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 71610-756). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, Llc, 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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Bottle Label 300 mg (71610 0753 94)

Gabapentin USP 300 mg capsules, package of 360 capsules. Label shows storage instructions, manufacturer Ascent Pharmaceuticals, Inc., and labeler Aphena Pharma Solutions - Tennessee, LLC. Includes NDC 71610-0753-94 and barcode.*

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Bottle Label 100 mg (71610 0756 30)

Gabapentin capsules 100 mg in a package of 30 capsules. The label includes storage instructions, a warning to keep out of children's reach, manufacturer information for Accord Pharmaceuticals, Inc., and packaging by Aphena Pharma Solutions - Tennessee, LLC. The NDC is 71610-0756-30.*

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Bottle Label 400 mg (71610 0757 53)

GABAPENTIN 400 mg oral capsule bottle label containing 60 capsules. The label includes the NDC 71610-0757-53 and states storage instructions between 20-25 degrees Celsius. Manufactured by Ascend Pharmaceuticals, Inc., and repackaged by Aphena Pharma, Cookeville, TN. The label includes batch and expiration information.*

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Aphena Pharma Solutions (TN)

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Equation (Equ)

An illustrated formula for calculating creatinine clearance (CLCr), featuring variables including age, weight, serum creatinine, and a multiplication factor for female patients.*

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Fig 1 (Fig 1)

A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 1' comparing mean pain scores over 8 weeks between placebo and gabapentin 3600 mg/day groups. The x-axis represents weeks (Baseline to 8 weeks) and the y-axis shows mean pain scores from 0 to 10. Gabapentin group shows a decreasing trend in pain scores, while placebo remains mostly stable.*

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Fig 2 (Fig 2)

A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 2' showing mean pain scores over an 8-week period. The graph compares three groups: Placebo, Gabapentin 1800 mg/day, and Gabapentin 2400 mg/day, with mean pain scores decreasing over time for both Gabapentin groups compared to placebo.*

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Fig 3 (Fig 3)

A bar graph showing the proportion of responders with at least 50% reduction in pain score at endpoint in controlled PHN studies. Study 1 compares placebo (12%) to GBP 3600 (29%), while Study 2 compares placebo (14%) to GBP 1800 (32%) and GBP 2400 (34%). Statistical significance markers indicate p values less than 0.01 and 0.001 for the gabapentin groups versus placebo.*

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Fig 4 (Fig 4)

A scatter plot showing responder rate differences (%) from placebo by daily gabapentin dose (mg) in three studies (a, b, c) for patients aged 12 and older with partial seizures. The x-axis indicates daily doses from 600 to 1800 mg, and the y-axis shows difference percentages from 2 to 22%. Data points are marked with black, light gray, and white squares corresponding to studies a, b, and c respectively.*

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Structure (Struct)

Chemical structure diagram of gabapentin, showing a cyclohexane ring attached to an amino group (CH2NH2) and a carboxyl group (CH2CO2H). This image represents 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' showing recommended dose ranges and regimens (QD, BID, TID) based on levels of creatinine clearance (mL/min) for patients, including post-hemodialysis supplemental doses. It provides dosage guidelines according to renal function categories and includes notes related to dosage adjustments and hemodialysis maintenance.*

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Table 2 (Tab 2)

Data table titled 'Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' showing columns for indication, event rates per 1,000 patients for placebo and drug patients, relative risk, and risk difference for epilepsy, psychiatric, other, and total categories.*

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Table 3 (Tab 3)

A data table titled 'Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' comparing the incidence percentages of various side effects between patients treated with gabapentin (N=336) and placebo (N=227). The table categorizes adverse reactions by body system, including the digestive system, metabolic and nutritional disorders, nervous system, respiratory system, and special senses, showing higher percentages of symptoms such as dizziness, somnolence, and peripheral edema in the gabapentin group.*

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Table 4 (Tab 4)

A table titled 'Adverse Reactions in Pooled Placebo-Controlled Add-On Trials in Epilepsy Patients >12 years of age' comparing percentages of various adverse reactions reported in patients treated with gabapentin versus placebo. Reactions are grouped by body systems 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)

Table showing adverse reactions in a placebo-controlled add-on trial of gabapentin versus placebo in pediatric epilepsy patients aged 3 to 12 years. The table lists the percentage of patients experiencing various side effects categorized by body system for gabapentin (N=119) and placebo (N=128) groups.*

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Tab 6 (Tab 6)

A data table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' displaying study duration, gabapentin target doses in mg/day, and the number of patients receiving gabapentin or placebo across two studies, including a total count. It notes doses are given in three divided doses (TID).*

* 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.