Enablex
Product Images NDC 54868-5704

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Enablex (NDC 54868-5704). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Physicians Total Care, 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

Enablex (darifenacin) Structural Formula (Enablex 03)

Chemical structure diagram of the active ingredient in Enablex, illustrating the molecular arrangement including a fused bicyclic ring system, a phenyl-substituted piperidine ring, and an amide group associated with the molecule's HBr salt form.*

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Figure 1 Mean (sd) Steady State Darifenacin Plasma Concentration Time Profiles For Enablex® 7.5 And 15 mg In Healthy Volunteers Including Both Cyp2d6 Ems And Pms* (Enablex 04)

A line graph showing mean darifenacin plasma concentration (ng/mL) with standard deviation over 24 hours post-dose. The graph compares two dosage groups of Enablex: 7.5 mg once daily and 15 mg once daily. The y-axis represents concentration from 0 to 10 ng/mL, while the x-axis represents time in hours after dosing.*

FDA Label Image

Figures 2 A,b,c. Median Change From Baseline At Weeks 2, 6, 12 For Number Of Incontinence Episodes Per Week (studies 1, 2 And 3) Figure 2a, Study 1 (Enablex 05)

A line graph showing median reduction (and 95% confidence interval) in incontinence episodes per week from baseline over 12 weeks. The graph compares placebo, Darifenacin 7.5 mg, and Darifenacin 15 mg groups, with reductions plotted at weeks 0, 2, 6, and 12. The Darifenacin groups show greater reduction compared to placebo over time.*

FDA Label Image

Figures 2 A,b,c. Median Change From Baseline At Weeks 2, 6, 12 For Number Of Incontinence Episodes Per Week (studies 1, 2 And 3) Figure 2b, Study 2 (Enablex 06)

A line graph depicting median reduction in incontinence episodes per week over 12 weeks with 95% confidence intervals. The graph compares three groups: Placebo, Darifenacin 7.5 mg, and Darifenacin 15 mg, showing greater reduction in episodes in the Darifenacin groups compared to placebo over time.*

FDA Label Image

Figures 2 A,b,c. Median Change From Baseline At Weeks 2, 6, 12 For Number Of Incontinence Episodes Per Week (studies 1, 2 And 3) Figure 2c, Study 3 (Enablex 07)

A line graph comparing the median reduction in incontinence episodes per week from baseline over 12 weeks between placebo and 15 mg Darifenacin. The y-axis shows the median reduction with confidence intervals, and the x-axis represents time in weeks. Data points indicate a greater reduction for Darifenacin compared to placebo.*

FDA Label Image

Principal Display Panel (7.5 mg)

Packaging label for Enablex 7.5 mg showing the lot number 000 and expiration date 01/60. Distributed by Physicians Total Care, Inc., Tulsa, OK. Manufactured by Novartis Pharma Stein AG, Stein, Switzerland. The label includes a barcode and NDC 54868-5704-0.*

FDA Label Image

Principal Display Panel (15 mg)

Enablex 15mg label distributed by Physicians Total Care, Inc. The label includes the NDC number 54868-5363-0, lot number 0000, and an expiration date of 01/60. It also notes manufacture by Novartis Pharma Stein AG, Stein, Switzerland, and contains a barcode.*

* 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.