Gabapentin Capsule
Product Images NDC 72865-253

Product Visual Gallery

This gallery contains 25 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 72865-253). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xlcare 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

100-180 (100 180)

Label for Gabapentin Capsules USP 100 mg by XLCare Pharmaceuticals, Inc. The label indicates the product contains 180 capsules for oral use. Storage instructions specify 25°C with permitted excursions, and the product is dispensed in child-resistant containers. Manufacturer and labeler addresses are also listed.*

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100-270 (100 270)

Label for Gabapentin Capsules, USP 100 mg by XLCare Pharmaceuticals, Inc. The package contains 270 capsules for oral use, prescription only. Storage instructions and manufacturer details are also included, with the label referencing the NDC number 72865-252-27.*

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100-500 (100 500)

Gabapentin Capsules USP 100 mg by XLCare Pharmaceuticals, Inc., in a bottle containing 500 capsules. The label includes storage instructions, manufacturer and labeler addresses, and indicates the product is prescription only (Rx Only). The label also includes the NDC code 72865-252-05.*

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100-90 (100 90)

Gabapentin Capsules, USP 100 mg oral capsules label from XLCare Pharmaceuticals, Inc. The label states 90 capsules per container with an NDC of 72865-252-90. Manufacturer and manufacturing information, storage instructions, and dosage usage notes appear in small text.*

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300-180 (300 180)

Label for Gabapentin Capsules USP 300 mg by XLCare Pharmaceuticals, Inc. The label indicates a package of 180 oral capsules. Storage instructions and manufacturer details are provided, including Central Islip, NY and Lawrenceville, GA addresses. The NDC code 72865-253-18 is visible.*

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300-270 (300 270)

Label for Gabapentin Capsules, USP 300 mg by XLCare Pharmaceuticals, Inc. The label states a package quantity of 270 capsules and includes storage instructions (25°C, with excursions permitted between 15°-30°C). It notes the product is Rx only and contains 300 mg of gabapentin per capsule. Manufacturing and labeling information for XLCare Pharmaceuticals, Inc. and Ascent Pharmaceuticals, Inc. is included.*

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300-30 (300 30)

GABAPENTIN Capsules, USP 300 mg oral capsules in a 30-count package from XLCare Pharmaceuticals, Inc. The label includes storage instructions, a barcode, and manufacturer information for Ascent Pharmaceuticals, Inc. and XLCare Pharmaceuticals, Inc., with a revision date of 06/23.*

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300-500 (300 500)

Label for Gabapentin Capsules, USP 300 mg oral capsules by XLCare Pharmaceuticals, Inc. The label includes the NDC 72865-253-05, package quantity of 500 capsules, and states Rx Only. Storage instructions and manufacturer addresses are also provided.*

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300-60 (300 60)

Label for Gabapentin Capsules USP 300 mg by XLcare Pharmaceuticals, Inc. The label includes the National Drug Code (NDC) 72865-253-60 and indicates a package size of 60 capsules. Storage instructions and manufacturing details for Ascent Pharmaceuticals, Inc. and XLcare Pharmaceuticals are also shown.*

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300-90 (300 90)

GABAPENTIN 300 mg Capsules, USP, oral prescription drug by XLCare Pharmaceuticals, Inc. The label indicates 90 capsules per container. Includes storage instructions and manufacture details for Ascent Pharmaceuticals and XLCare Pharmaceuticals, Inc.*

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400-270 (400 270)

Label for Gabapentin Capsules, USP 400 mg by XLCare Pharmaceuticals, Inc. The label indicates the package contains 270 capsules for oral use. It includes storage instructions, dosing directions referencing the package insert, and manufacturer details for Ascent Pharmaceuticals, Inc., with labeling by XLCare Pharmaceuticals, Inc.*

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400-500 (400 500)

Label for Gabapentin Capsules, USP 400 mg by XLCare Pharmaceuticals, Inc. The label specifies 500 capsules in the package, oral dosage form, and prescription use only. Instructions for storage at 25°C with allowable excursions and dispensing in child-resistant containers are included. The label lists the manufacturer as Ascent Pharmaceuticals, Inc. and the labeler as XLCare Pharmaceuticals, Inc.*

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400-90 (400 90)

Label for Gabapentin Capsules USP 400 mg by XLCare Pharmaceuticals, Inc. The package contains 90 oral capsules. The label includes storage instructions, manufacturer details, and the note that it is for prescription use only. NDC 72865-254-90 is visible on the label.*

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Equation (Equ)

An illustration showing the formula for calculating Creatinine Clearance (CLCr). The formula involves age, weight, serum creatinine, and includes a multiplication adjustment factor of 0.85 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. It shows two lines representing placebo and gabapentin 3600 mg/day, with time on the x-axis (weeks) and mean pain score on the y-axis, illustrating a decrease in pain scores for gabapentin compared to placebo.*

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Fig 2 (Fig 2)

A line graph titled 'Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 2' comparing mean pain scores over 7 weeks among placebo and two gabapentin dose groups (1800 mg/day and 2400 mg/day). The x-axis represents weeks from baseline to week 7, and the y-axis shows mean pain scores from 0 to 10. Gabapentin groups show lower mean pain scores than placebo over time.*

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Fig 3 (Fig 3)

A bar chart showing the proportion of responders with at least 50% reduction in pain score at endpoint across two controlled PHN studies. The x-axis shows treatment groups including placebo (PBO) and gabapentin (GBP) at different doses (1800, 2400, 3600 mg), while the y-axis represents percentage responders from 0% to 100%. Study 1 compares PBO (12%) to GBP 3600 mg (29%), Study 2 compares PBO (14%) to GBP 1800 mg (32%) and GBP 2400 mg (34%). Statistical significance is indicated with p-values less than 0.01 and 0.001.*

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Fig 4 (Fig 4)

A bar graph illustrating responder rates in patients receiving gabapentin compared to placebo, by daily dose (600 to 1800 mg) and study type (Study a, Study b, Study c). The vertical axis shows percentage difference, with distinct markers representing each study at various dose points in patients aged 12 years and older with partial seizures.*

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Structure (Struct)

Chemical structure diagram showing the molecular arrangement of gabapentin. The structure highlights a cyclohexane ring attached to an amino methyl group (CH2NH2) and a carboxymethyl group (CH2CO2H).*

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Table 1 (Tab 1)

A data table titled 'Gabapentin Dosage Based on Renal Function' showing dosing guidelines for gabapentin capsules according to levels of creatinine clearance in mL/min. The table details total daily dose ranges and dose regimens in mg for various renal function categories, with additional supplemental dosing recommendations post-hemodialysis. Abbreviations for dose frequency (TID, BID, QD) are defined, and footnotes address dosing adjustments for patients with impaired renal function and hemodialysis treatment.*

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Table 2 (Tab 2)

A data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' presenting comparative risks of events among placebo and drug patients per 1,000 patients across indications including Epilepsy, Psychiatric, and Other. It shows relative risk and risk differences for the antiepileptic drugs evaluated.*

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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 rates (%) of various adverse reactions between gabapentin (N=336) and placebo (N=227). The table categorizes adverse reactions under body systems such as body as a whole, digestive system, metabolic and nutritional disorders, nervous system, respiratory system, and special senses, listing specific symptoms with their corresponding percentage occurrences in each group.*

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Table 4 (Tab 4)

A data table titled 'Adverse Reactions in Pooled Placebo-Controlled Add-On Trials In Epilepsy Patients >12 years of age' showing the percentage of various adverse reactions reported for gabapentin and placebo groups. Reactions are categorized by body system, including Body As A Whole, Cardiovascular, Digestive System, Nervous System, Respiratory System, Skin and Appendages, Urogenital System, and Special Senses, with frequency percentages listed for each treatment group out of sample sizes N=543 for gabapentin and N=378 for placebo.*

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Table 5 (Tab 5)

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 various adverse reactions in patients treated with gabapentin versus placebo. Categories include body as a whole, digestive system, nervous system, and respiratory system, showing specific reactions like viral infection, fever, nausea, somnolence, hostility, and respiratory infection.*

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Tab 6 (Tab 6)

Data table titled 'TABLE 6. Controlled PHN Studies: Duration, Dosages, and Number of Patients' summarizing two studies involving gabapentin. It includes columns for study number, study duration (7 to 8 weeks), gabapentin target dose in mg/day (ranging from 1800 to 3600 mg), and counts of patients receiving gabapentin or placebo.*

* 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.