Pregabalin Capsule
Product Images NDC 69238-1317

21 FDA label images from Amneal Pharmaceuticals Ny Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 21 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 69238-1317). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals Ny 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.

FDA Label Image

10 (Pregabalin Capsules 1)

10 (Pregabalin Capsules 1)
An illustration showing the formula for calculating creatinine clearance (CLCr): ((140 minus age in years) times weight in kg) divided by (72 times serum creatinine in mg/dL), multiplied by 0.85 for female patients.*
FDA Label Image

F-8 (Pregabalin Capsules 10)

F-8 (Pregabalin Capsules 10)
A line graph showing the percentage of patients improved versus percent improvement in pain from baseline for Pregabalin at 300 mg, 450 mg, and 600 mg daily doses compared to placebo. The graph illustrates a decreasing trend in patient improvement percentage as pain improvement increases, with vertical lines marking specific points on the x-axis.*
FDA Label Image

Fig-9 (Pregabalin Capsules 11)

Fig-9 (Pregabalin Capsules 11)
A Kaplan-Meier survival curve chart comparing the estimated percentage of subjects without LTR over time in days for Pregabalin versus Placebo groups. The vertical axis shows the percentage of subjects without LTR from 0% to 100%, and the horizontal axis shows days from 0 to 180.*
FDA Label Image

F-10 (Pregabalin Capsules 12)

F-10 (Pregabalin Capsules 12)
A line graph depicting the percent of subjects improved over time, comparing Pregabalin and placebo groups. The x-axis shows percent improvement from baseline to week 12 BOCF, and the y-axis shows the percent of subjects improved, with Pregabalin represented by a solid line and placebo by a dotted line.*
FDA Label Image

F-11 (Pregabalin Capsules 13)

F-11 (Pregabalin Capsules 13)
A line graph comparing the percent of subjects improved over a range of percent improvement from baseline to Week 16 BOCF. The graph displays two curves representing Pregabalin and Placebo, with the vertical axis showing percent of subjects improved and the horizontal axis showing percent improved from baseline. The Pregabalin curve consistently lies above the Placebo curve, indicating a higher percentage of subjects improved on Pregabalin.*
FDA Label Image

1 (Pregabalin Capsules 14)

1 (Pregabalin Capsules 14)
Pregabalin Capsules 25 mg label from Amneal Pharmaceuticals NY LLC. It is an oral capsule product with 90 capsules per container. The label includes storage instructions, usage notes, a pharmacist advisory, and a scannable QR code linking to a medication guide.*
FDA Label Image

1 (Pregabalin Capsules 15)

1 (Pregabalin Capsules 15)
Label for Pregabalin Capsules 50 mg by Amneal Pharmaceuticals NY LLC. The label indicates this is an oral capsule prescription drug containing 90 capsules per bottle. Important storage instructions and dosage guidance are included along with a pharmacist note to dispense the medication guide to each patient. The NDC number, manufacturer, and distributor information are also present.*
FDA Label Image

1 (Pregabalin Capsules 16)

1 (Pregabalin Capsules 16)
Pregabalin Capsules 75 mg oral capsules label from Amneal Pharmaceuticals NY LLC. The label includes dosage strength, quantity of 90 capsules, NDC number 69238-1312-9, storage instructions, and dispensing guidance. It features the Amneal logo and a QR code linking to the medication guide.*
FDA Label Image

1 (Pregabalin Capsules 17)

1 (Pregabalin Capsules 17)
Label for Pregabalin Capsules 100 mg by Amneal Pharmaceuticals NY LLC. The label indicates 90 capsules per container, prescription only (Rx only), with dosing, storage, and manufacturer details. Includes a QR code linking to the medication guide and a barcode for scanning.*
FDA Label Image

1 (Pregabalin Capsules 18)

1 (Pregabalin Capsules 18)
Label for Pregabalin Capsules 150 mg by Amneal Pharmaceuticals NY LLC, oral solid dosage form. The label shows a package of 90 capsules. Storage instructions and distributor information for Amneal Pharmaceuticals LLC are included, along with a QR code linking to the medication guide.*
FDA Label Image

1 (Pregabalin Capsules 19)

1 (Pregabalin Capsules 19)
Label of Pregabalin Capsules 200 mg by Amneal Pharmaceuticals NY LLC. The label indicates the product contains 90 capsules, each with 200 mg of pregabalin. Storage instructions specify keeping between 20° to 25°C (68° to 77°F) with permitted excursions. The label notes it is Rx only and advises dispensing the Medication Guide to each patient. Manufacturing and distribution details are provided along with a barcode and a QR code linking to the medication guide.*
FDA Label Image

Structure (Pregabalin Capsules 2)

Structure (Pregabalin Capsules 2)
Chemical structure of pregabalin, the active ingredient depicted with its molecular formula showing key functional groups including a carboxylic acid (CO2H) and an amine (NH2) attached to the carbon backbone.*
FDA Label Image

1 (Pregabalin Capsules 20)

1 (Pregabalin Capsules 20)
Pregabalin Capsules 225 mg label from Amneal Pharmaceuticals NY LLC. The label shows 90 capsules, Rx only, with storage instructions and manufacturing information. The label includes a capsule image with imprint 'AN 316' and details on usual dosage and handling.*
FDA Label Image

1 (Pregabalin Capsules 21)

1 (Pregabalin Capsules 21)
Pregabalin Capsules 300 mg label from Amneal Pharmaceuticals NY LLC. The label indicates prescription use with 90 capsules per container. Storage instructions specify 20°C to 25°C (68°F to 77°F) with allowable excursions and controlled room temperature. The label includes a QR code for the medication guide and lists manufacturing and distribution information for Amneal Pharmaceuticals Pvt. Ltd. in India and Amneal Pharmaceuticals LLC in Bridgewater, NJ.*
FDA Label Image

F1 (Pregabalin Capsules 3)

F1 (Pregabalin Capsules 3)
A line graph depicting the percent improvement in pain from baseline versus the percent of patients improved. The graph compares Pregabalin 200 mg, 100 mg, and 25 mg taken three times a day, along with a placebo group. The graph shows multiple trend lines representing each dosage and placebo across the percentage of pain improvement.*
FDA Label Image

F-2 (Pregabalin Capsules 4)

F-2 (Pregabalin Capsules 4)
A line graph showing the percent of patients improved versus percent improvement in pain from baseline. The graph compares Pregabalin 100 mg three times a day to placebo, illustrating higher patient improvement rates with Pregabalin across various levels of pain improvement.*
FDA Label Image

F-3 (Pregabalin Capsules 5)

F-3 (Pregabalin Capsules 5)
A line graph showing the percent of patients improved plotted against the percent improvement in pain from baseline. The graph compares Pregabalin dosages of 300 mg, 150 mg, and 75 mg taken two times a day with placebo, illustrating effectiveness by percentage of patients experiencing improvement.*
FDA Label Image

F-4 (Pregabalin Capsules 6)

F-4 (Pregabalin Capsules 6)
A line graph comparing the percent of patients improved against the percent improvement in pain from baseline. The graph shows three lines representing Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo, illustrating patient response over various improvement ranges.*
FDA Label Image

F-5 (Pregabalin Capsules 7)

F-5 (Pregabalin Capsules 7)
A line graph comparing the percent of patients improved against the percent improvement in pain from baseline for Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo groups. The graph shows the distributions of patient-reported pain improvements for each treatment.*
FDA Label Image

F-6 (Pregabalin Capsules 8)

F-6 (Pregabalin Capsules 8)
A bar chart comparing responder rates (%) in two studies (Study E1 and Study E3) for different daily doses of pregabalin versus placebo. Study E1 shows increasing responder rates from placebo to 600 mg/day with BID dosing, while Study E3 compares placebo to 600 mg/day with BID and TID dosing, showing higher responder rates for 600 mg TID. The horizontal axis represents treatment groups and the vertical axis shows responder rate percentages.*
FDA Label Image

F-7 (Pregabalin Capsules 9)

F-7 (Pregabalin Capsules 9)
A line graph depicting seizure reduction as median percentage change from baseline against dose in mg/day for Pregabalin. It compares four study groups (E1 BID, E2 TID, E3 BID, E3 TID) with dose ranges from 0 (placebo) to 600 mg/day, showing increasing seizure reduction with higher doses. The graph includes p-values indicating statistical significance at various dose points.*

* 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.