Bisoprolol Fumarate And Hydrochlorothiazide Tablet, Film Coated
Product Images NDC 42799-920

14 FDA label images from Edenbridge Pharmaceuticals Llc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Bisoprolol Fumarate And Hydrochlorothiazide (NDC 42799-920). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Edenbridge Pharmaceuticals 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

Biso Api Structure (Api Pic New1)

Biso Api Structure (Api Pic New1)
Chemical structure of Bisoprolol Fumarate and Hydrochlorothiazide, depicting molecular components and bonds associated with the active ingredients in the combination drug.*
FDA Label Image

Hctz Api Structure (Api Pic New2)

Hctz Api Structure (Api Pic New2)
Chemical structure of the active ingredient bisoprolol fumarate and hydrochlorothiazide, shown as a molecular diagram with labeled atoms and chemical bonds.*
FDA Label Image

1 (Table 1)

1 (Table 1)
A data table presenting the mean decrease in sitting systolic/diastolic blood pressure (BP) and heart rate (HR) after 3 to 4 weeks from two studies. It compares placebo with various strengths of Bisoprolol Fumarate and Hydrochlorothiazide (B 5/ H 6.25 mg, B 6.25 mg, B 2.5/ H 6.25 mg, B 10/ H 6.25 mg), including the number of subjects and observed changes in BP and HR values.*
FDA Label Image

1 (Table 2)

1 (Table 2)
A table presenting the percentage of patients experiencing adverse experiences related to Bisoprolol Fumarate and Hydrochlorothiazide (B2.5-40/H6.25 and B2.5-10/H6.25) compared to placebo. It categorizes adverse events by body system, including cardiovascular, respiratory, central nervous system, musculoskeletal, psychiatric, gastrointestinal, and others, detailing all adverse experiences and drug-related adverse experiences across study groups.*
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1 (Table 3)

1 (Table 3)
A data table titled "Serum Potassium Data from U.S. Placebo Controlled Studies" comparing mean change in potassium levels and hypokalemia percentage among groups treated with placebo, Bisoprolol Fumarate and Hydrochlorothiazide (B2.5/H6.25 mg, B5/H6.25 mg, B10/H6.25 mg), and Hydrochlorothiazide 25 mg alone. The table presents sample sizes and clarifies data annotations for combined studies, baseline serum potassium, mean changes at Week 4, and percentage of patients with abnormality at Week 4.*
FDA Label Image

1 (25mg 30ct)

1 (25mg 30ct)
Label for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg / 6.25 mg. The label states the package contains 30 film-coated tablets for oral use, manufactured by Edenbridge Pharmaceuticals LLC and marketed under Dexcel Pharma. Storage instructions and dosage cautions are also shown, along with a barcode and the NDC number 42799-920-30.*
FDA Label Image

1 (5mg 30ct)

1 (5mg 30ct)
Label for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, with strength 5 mg / 6.25 mg. The label indicates 30 film-coated tablets in a unit-of-use package. Manufactured for Edenbridge Pharmaceuticals LLC by Dexcel Pharma USA, the label includes storage instructions (20° to 25°C), dosage advisory to see package brochure, and a barcode.*
FDA Label Image

1 (25mg 100ct)

1 (25mg 100ct)
Label for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 2.5 mg / 6.25 mg film-coated tablets. The label shows a quantity of 100 tablets, NDC 42799-920-01, manufactured for Edenbridge Pharmaceuticals LLC by Dexcel Pharma USA, Parsippany, NJ. The label includes storage directions and a barcode. It also indicates the product is Rx only and features the Dexcel Pharma logo.*
FDA Label Image

1 (5mg 100ct)

1 (5mg 100ct)
Label for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 5 mg / 6.25 mg, film-coated tablets by Edenbridge Pharmaceuticals LLC. The package contains 100 tablets. Storage instructions and dosage directions advise consulting the accompanying brochure. The label includes the NDC 42799-921-01 and a barcode.*
FDA Label Image

1 (25mg 500ct)

1 (25mg 500ct)
Label for Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 2.5 mg / 6.25 mg, film-coated tablets in a 500 count package. The label highlights the active ingredients and their strengths, storage instructions at 20° to 25°C, and directs users to the accompanying package brochure for dosage information. Manufactured for Edenbridge Pharmaceuticals LLC.*
FDA Label Image

1 (5mg 500ct)

1 (5mg 500ct)
Label for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, strength 5 mg / 6.25 mg. The film-coated tablet package contains 500 tablets. The label includes storage instructions and manufacturer information for Edenbridge Pharmaceuticals LLC, DBA Dexcel Pharma USA.*
FDA Label Image

1 (10mg 30ct)

1 (10mg 30ct)
Label for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 10 mg / 6.25 mg film-coated tablets. The package contains 30 tablets for oral use. Manufactured for Edenbridge Pharmaceuticals LLC, DBA Dexcel Pharma USA. Storage instructions and bar code are included on the label.*
FDA Label Image

1 (10mg 100ct)

1 (10mg 100ct)
Box label for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 10 mg / 6.25 mg, film-coated tablets. The package contains 100 tablets. Label includes storage instructions at 20° to 25°C and dispensing in a tight container. Manufactured for Edenbridge Pharmaceuticals LLC, DBA Dexcel Pharma USA. The label also shows the NDC number 42799-922-01.*
FDA Label Image

1 (10mg 500ct)

1 (10mg 500ct)
Label for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 10 mg / 6.25 mg strength, film-coated tablet. The package contains 500 tablets. Manufactured for Edenbridge Pharmaceuticals LLC, Dexcel Pharma USA. Includes storage instructions and dosage note referencing the package brochure. Barcode and NDC 42799-922-02 visible.*

* 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.