Gabapentin Capsule
Product Images NDC 68071-3664

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 68071-3664). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nucare 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

Pdp (68071 3664 4)

Label for Gabapentin 100 mg capsules, containing 40 capsules, manufactured by NuCare Pharmaceuticals, Inc. The label includes the National Drug Code (NDC) 68071-3664, product number P1228040, and storage instructions to keep at controlled temperature 68-77°F. It states each capsule contains 100 mg of gabapentin in an oblong white opaque capsule marked with 'A' on the cap and '469' on the body.*

FDA Label Image

Equation (Equ)

The image shows a formula used to calculate creatinine clearance (CLCr), which incorporates age in years, weight in kilograms, serum creatinine level in mg/dL, and a correction factor of 0.85 for female patients.*

FDA Label Image

Fig 1 (Fig 1)

A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 1' showing mean pain scores on the Y-axis over 8 weeks on the X-axis. Two lines compare pain scores for placebo and gabapentin 3600 mg/day, with a decrease in pain scores for gabapentin over time, while placebo remains relatively stable. The graph indicates an 8-week study with a 4-week dose titration period followed by a 4-week fixed dose period.*

FDA Label Image

Fig 2 (Fig 2)

A line graph showing weekly mean pain scores over seven weeks in an ITT population during Study 2. The graph compares pain scores for placebo, gabapentin 1800 mg/day, and gabapentin 2400 mg/day across baseline and weekly intervals. Mean pain scores decrease slightly over time for both gabapentin groups compared to placebo.*

FDA Label Image

Fig 3 (Fig 3)

Bar graph depicting the proportion of responders with at least 50% reduction in pain score at endpoint in controlled PHN studies. It compares placebo (PBO) and gabapentin (GBP) doses across two studies, showing higher response rates for gabapentin groups (29% at 3600 mg in Study 1, and 32% at 1800 mg and 34% at 2400 mg in Study 2) versus placebo groups (12% and 14%). Statistical significance markers are included.*

FDA Label Image

Fig 4 (Fig 4)

A scatter plot showing the responder rate difference (%) in patients receiving gabapentin versus placebo by daily dose (mg) across three studies labeled a, b, and c. The x-axis represents daily dose ranging from about 600 to 1800 mg, and the y-axis represents percentage difference up to 22%. Data points for Studies a, b, and c at various doses are marked with distinct square symbols and alphabetical labels.*

FDA Label Image

Structure (Struct)

Chemical structure diagram of gabapentin showing a cyclohexane ring bonded to an amino methyl (CH2NH2) group and a carboxymethyl (CH2CO2H) group.*

FDA Label Image

Table 1 (Tab 1)

A data table titled 'Gabapentin Dosage Based on Renal Function,' presenting dosing regimens for gabapentin capsules by creatinine clearance levels in mL/min. It details total daily dose ranges and specific dose regimens for various levels of renal function, including post-hemodialysis supplemental doses, with dosing frequency explained as TID, BID, and QD.*

FDA Label Image

Table 2 (Tab 2)

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

FDA Label Image

Table 3 (Tab 3)

A data table titled 'Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia' comparing percentages of various adverse reactions between Gabapentin (N=336) and Placebo (N=227). The table is organized by body systems and lists reactions such as asthenia, infection, diarrhea, dizziness, and others with their respective incidence rates for both groups.*

FDA Label Image

Table 4 (Tab 4)

A data table displaying adverse reactions in pooled placebo-controlled add-on trials for epilepsy patients over 12 years old comparing gabapentin (N=543) and placebo (N=378). Reactions are categorized by body system, including fatigue, somnolence, dizziness, and diplopia, with percentages for each group. Footnotes specify adjunctive therapy and detail on amblyopia.*

FDA Label Image

Table 5 (Tab 5)

A data table titled 'Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years' comparing the percentage of patients experiencing specific adverse reactions between gabapentin (N=119) and placebo (N=128). Reactions are categorized by body system, including Body As A Whole, Digestive System, Nervous System, and Respiratory System, with corresponding percentages for each group.*

FDA Label Image

Tab 6 (Tab 6)

A data table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' presenting two study rows detailing gabapentin target doses in mg/day, study durations, and patient counts for gabapentin and placebo groups. The table shows study durations of 8 and 7 weeks with doses 3600, and 1800/2400 mg respectively, plus total patient numbers.*

* 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.