Gabapentin
Product Images NDC 10544-557

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 10544-557). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Blenheim Pharmacal, 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

7d5ebe51-figure-06 (Label Gabapentin Caps 400mg Bpi(10544 557 90) Camber(31722 223 05) Rev2)

Label for Gabapentin Capsules, USP 400 mg, containing 90 capsules. Label shows NDC 10544-557-90 and manufacturer Blenheim Pharmacal, Inc. It includes storage instructions, batch number, and barcodes. The label indicates prescription use (Rx Only) with guidance to see package insert for dosage.*

FDA Label Image

Fig1-2-3 (Fig123)

Three figures presenting data from controlled PHN studies with Gabapentin. Figure 1 shows weekly mean pain scores over 8 weeks comparing placebo and Gabapentin 3600 mg/day, with results decreasing more for Gabapentin. Figure 2 shows weekly mean pain scores over 7 weeks comparing placebo, Gabapentin 1800 mg/day, and 2400 mg/day, showing greater pain reduction with Gabapentin. Figure 3 is a bar chart of responder proportions with ≥50% pain score reduction at endpoint, indicating higher percentages for Gabapentin doses compared to placebo in two studies.*

FDA Label Image

Fig4 (Fig4)

A scatter plot displaying the percentage difference on the y-axis against daily dose in milligrams on the x-axis, with data points labeled 'a', 'b', and 'c'. The graph compares three studies labeled STUDY a, STUDY b, and STUDY c, differentiated by black, gray, and white square markers respectively, across dose levels of approximately 600, 900, 1200, and 1800 mg.*

FDA Label Image

Table1 (Img1)

A data table titled 'TABLE 1. Gabapentin Dosage Based on Renal Function' presenting dosage regimens of Gabapentin according to renal function measured by creatinine clearance (mL/min). The table includes total daily dose ranges and specific dose regimens in mg for different levels of renal function, as well as a post-hemodialysis supplemental dose section. Additional notes explain dosage adjustments for patients with low creatinine clearance, guidelines for hemodialysis dosing, a formula for estimating creatinine clearance, and a caution on use in patients under 12 years with compromised renal function.*

FDA Label Image

Structure (Struct)

Chemical structure diagram of Gabapentin showing a cyclohexane ring with amino and carboxyethyl side groups.*

FDA Label Image

Table-2 (Tab2)

A data table titled 'Risk by indication for antiepileptic drugs in the pooled analysis' showing incidence rates of events per 1000 patients for placebo and drug groups across indications: Epilepsy, Psychiatric, and Other. It includes columns for Relative Risk and Risk Difference between drug and placebo patients.*

FDA Label Image

Tab3 (Tab3)

Data table showing adverse reactions in pooled placebo-controlled trials for postherpetic neuralgia comparing Gabapentin (N=336) and placebo (N=227). Reactions are categorized by body system, including body as a whole, digestive, metabolic and nutritional, nervous, respiratory, and special senses, with percentages for each group. Notable differences include higher rates of dizziness, somnolence, and peripheral edema in the Gabapentin group.*

FDA Label Image

Tab4 (Tab4)

Table showing adverse reactions in pooled placebo-controlled add-on trials in epilepsy patients over 12 years of age, comparing Gabapentin (N=543) and Placebo (N=378). Reactions are categorized by system (Body, Cardiovascular, Digestive, Nervous, Respiratory, Skin, Urogenital, Special Senses) with percentage incidence listed for each group, indicating higher frequency of several symptoms such as somnolence, dizziness, and fatigue for Gabapentin.*

FDA Label Image

Tab5 (Tab5)

Table showing adverse reactions in a placebo-controlled add-on trial for pediatric epilepsy patients aged 3 to 12 years, comparing Gabapentin (N=119) and placebo (N=128). Adverse reactions are categorized by body system including general body symptoms, digestive system, nervous system, and respiratory system, with percentages listed for each reaction type in both groups.*

FDA Label Image

Table-6 (Tab6)

A data table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' presenting information on two clinical studies. Columns include Study, Study Duration, Gabapentin Target Dose (mg/day), Patients Receiving Gabapentin, and Patients Receiving Placebo. The table details study durations of 7 to 8 weeks, dosages ranging from 1800 to 3600 mg/day, and patient counts for both gabapentin and placebo 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.