Gabapentin
Product Images NDC 52959-789

9 FDA label images from H.j. Harkins Company, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 52959-789). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by H.j. Harkins Company, 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

Structural Formula For Gabapentin (56a21e7c Ffab 4034 9682 491a7b5cfff7 01)

Structural Formula For Gabapentin (56a21e7c Ffab 4034 9682 491a7b5cfff7 01)
Chemical structure of the active ingredient gabapentin, showing a cyclohexane ring with an amino group (CH2NH2) and an acetic acid group (CH2CO2H) attached.*
FDA Label Image

Figure 1 (56a21e7c Ffab 4034 9682 491a7b5cfff7 02)

Figure 1 (56a21e7c Ffab 4034 9682 491a7b5cfff7 02)
A line graph showing mean pain scores over 8 weeks comparing Gabapentin 3600 mg/day to placebo. The x-axis represents weeks, including a 4-week dose titration period followed by a 4-week fixed dose period. The y-axis shows mean pain scores ranging from 1 to 10. Gabapentin group shows a significant reduction in mean pain scores compared to placebo over time. The graph notes statistical significance at p < 0.01.*
FDA Label Image

Figure 2 (56a21e7c Ffab 4034 9682 491a7b5cfff7 03)

Figure 2 (56a21e7c Ffab 4034 9682 491a7b5cfff7 03)
A line graph showing mean pain scores over a 7-week period, including a 3-week dose titration period and a 4-week fixed dose period. It compares placebo with Gabapentin at dosages of 1800 mg/day and 2400 mg/day, with pain scores decreasing more significantly for Gabapentin groups compared to placebo.*
FDA Label Image

Figure 3 (56a21e7c Ffab 4034 9682 491a7b5cfff7 04)

Figure 3 (56a21e7c Ffab 4034 9682 491a7b5cfff7 04)
A bar chart comparing the percentage of responders at endpoint for gabapentin (GBP) and placebo (PBO) in 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 with p-values less than 0.01 and 0.001 for gabapentin versus placebo.*
FDA Label Image

Figure 4 (56a21e7c Ffab 4034 9682 491a7b5cfff7 05)

Figure 4 (56a21e7c Ffab 4034 9682 491a7b5cfff7 05)
A scatter plot comparing the percentage difference across three studies labeled a, b, and c, plotting percentage difference on the vertical axis and daily gabapentin dose in mg on the horizontal axis, with doses around 600 to 1800 mg.*
FDA Label Image

Table 5 (56a21e7c Ffab 4034 9682 491a7b5cfff7 06)

Table 5 (56a21e7c Ffab 4034 9682 491a7b5cfff7 06)
A data table showing dosing guidelines for Gabapentin based on renal function measured as creatinine clearance (mL/min). It lists total daily dose ranges (mg/day) and dose regimens (mg) for different clearance levels (>60, 30-59, 15-29, 15a), including post-hemodialysis supplemental doses, and notes on dose adjustments for patients with reduced clearance.*
FDA Label Image

Glenmark Logo (56a21e7c Ffab 4034 9682 491a7b5cfff7 08)

FDA Label Image

Gabapentin Tablets 600 mg Bottle Label (56a21e7c Ffab 4034 9682 491a7b5cfff7 09)

Gabapentin Tablets 600 mg Bottle Label (56a21e7c Ffab 4034 9682 491a7b5cfff7 09)
The label for Gabapentin 600mg tablet displays the drug name and strength prominently. It includes lot number GBT626KG, manufacturer Glenmark (India), expiration date 11/10, and identifies the pills as white round tablets. The label compares this product to Neurontin and notes the pill count is 120 tablets. Additional instructions advise to take as directed by a doctor or refer to the outsert for dosage information. Manufacturer details and regulatory warnings are also present.*
FDA Label Image

Gabapentin Tablets 800 mg Bottle Label (56a21e7c Ffab 4034 9682 491a7b5cfff7 10)

Gabapentin Tablets 800 mg Bottle Label (56a21e7c Ffab 4034 9682 491a7b5cfff7 10)
Gabapentin 800mg tablet label showing product name, strength, and dosage form. The label includes lot number GAP812KG, expiration date 03/11, manufacturer Glenmark with India manufacturing site, and compares the product to Neurontin. It mentions white round tablets and includes cautionary text and barcode. The labeler is H.J. Harkins Company, Inc.*

* 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.