Amlodipine, Valsartan, Hydrochlorothiazide Tablet, Film Coated
Product Images NDC 64380-198

13 FDA label images from Strides Pharma Science Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Amlodipine, Valsartan, Hydrochlorothiazide (NDC 64380-198). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Strides Pharma Science Limited, 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

Amlodipine-structure (516dd621 45ae 4fc8 8507 23d43b6d7a7e 40)

Amlodipine-structure (516dd621 45ae 4fc8 8507 23d43b6d7a7e 40)
Chemical structure diagram depicting the molecular formula of amlodipine besylate, showing its aromatic rings, chlorine atom, and ester groups, alongside the structure of a sulfonic acid group representative of the besylate component.*
FDA Label Image

Valsartan-structure (516dd621 45ae 4fc8 8507 23d43b6d7a7e 41)

Valsartan-structure (516dd621 45ae 4fc8 8507 23d43b6d7a7e 41)
Chemical structure diagram showing the molecular structure of amlodipine, an active ingredient in the AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE combination product. The diagram depicts the arrangement of atoms and bonds characteristic of amlodipine besylate.*
FDA Label Image

Hctz-structure (516dd621 45ae 4fc8 8507 23d43b6d7a7e 42)

Hctz-structure (516dd621 45ae 4fc8 8507 23d43b6d7a7e 42)
Chemical structure diagram of amlodipine besylate, showing the molecular arrangement including benzene ring, chlorine, sulfonamide, and amine groups. This structure corresponds to the active ingredient amlodipine besylate used in the combination tablet product by Strides Pharma Science Limited.*
FDA Label Image

Figure1 (516dd621 45ae 4fc8 8507 23d43b6d7a7e 43)

Figure1 (516dd621 45ae 4fc8 8507 23d43b6d7a7e 43)
A bar chart titled 'Reduction in Mean Blood Pressure at Endpoint,' comparing reductions in diastolic and systolic blood pressure for four different treatments: HCTZ/Aml 25/10, Val/HCTZ 320/25, Aml/Val 10/320, and Aml/Val/NCTZ 10/320/25. Each treatment shows numerical reduction values for both diastolic and systolic BP with systolic reductions larger in magnitude.*
FDA Label Image

Figure2 (516dd621 45ae 4fc8 8507 23d43b6d7a7e 44)

Figure2 (516dd621 45ae 4fc8 8507 23d43b6d7a7e 44)
Line graph illustrating mean sitting diastolic blood pressure (mmHg) over eight weeks by treatment group for amlodipine, valsartan, and hydrochlorothiazide combinations. The x-axis represents weeks from 0 to 8, and the y-axis shows blood pressure values from approximately 80 to 110 mmHg. Four treatment groups with different dosage combinations are plotted using distinct symbols and line styles, showing trends in blood pressure reduction over time.*
FDA Label Image

Figure3 (516dd621 45ae 4fc8 8507 23d43b6d7a7e 45)

Figure3 (516dd621 45ae 4fc8 8507 23d43b6d7a7e 45)
Line graph titled 'Mean Sitting Systolic Blood Pressure by Treatment and Week' showing mean sitting systolic blood pressure (mmHg) over 8 weeks. The graph compares four treatments: Aml/Val/HCTZ 10/320/25 mg, Aml/Val 10/320 mg, Val/HCTZ 320/25 mg, and HCTZ/Aml 25/10 mg, each represented by different line styles and markers. Blood pressure decreases over time with differences in treatment responses.*
FDA Label Image

Figure4 (516dd621 45ae 4fc8 8507 23d43b6d7a7e 46)

Figure4 (516dd621 45ae 4fc8 8507 23d43b6d7a7e 46)
A line graph titled 'Mean Ambulatory Diastolic Blood Pressure at Endpoint by Treatment and Hour' showing diastolic blood pressure (mmHg) on the y-axis and hours after dosing on the x-axis. The chart compares four treatments with different amlodipine, valsartan, and hydrochlorothiazide dose combinations over a 24-hour period.*
FDA Label Image

Figure5 (516dd621 45ae 4fc8 8507 23d43b6d7a7e 47)

Figure5 (516dd621 45ae 4fc8 8507 23d43b6d7a7e 47)
A line graph titled 'Mean Ambulatory Systolic Blood Pressure at Endpoint by Treatment and Hour' displaying mean ambulatory systolic blood pressure (mmHg) on the vertical axis and hours after dosing on the horizontal axis. Four treatment groups are compared: Aml/Val/HCTZ 10/320/25 mg, Val/HCTZ 320/25 mg, Aml/Val 10/320 mg, and HCTZ/Aml 25/10 mg, each represented by distinct line markers and patterns.*
FDA Label Image

5 mg/160 mg/12.5 mg (30 tablets)

5 mg/160 mg/12.5 mg (30 tablets)
Label for Amlodipine/Valsartan/Hydrochlorothiazide tablets, strength 5 mg/160 mg/12.5 mg. The label includes dosage form and quantity: 30 film-coated tablets. Manufacturer information shows Strides Pharma Inc. and distributor Strides Pharma Inc., East Brunswick, NJ. The label also includes storage instructions and an NDC number.*
FDA Label Image

5 mg/160 mg/25 mg (30 tablets)

5 mg/160 mg/25 mg (30 tablets)
A drug label for Amlodipine/Valsartan/Hydrochlorothiazide 5 mg/160 mg/25 mg tablets. The label includes dosage strength highlighted in a purple box and states the product contains 30 film-coated tablets. It features the Strides Pharma Inc. logo and indicates the product is Rx only. Storage instructions and warnings to keep out of reach of children are also visible, along with a barcode and NDC 64380-198-01.*
FDA Label Image

10 mg/160 mg/12.5 mg (30 tablets)

10 mg/160 mg/12.5 mg (30 tablets)
Label for Amlodipine/Valsartan/Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg by Strides Pharma Inc. The label includes dosage information, storage instructions, and states the package contains 30 tablets. The label features the NDC number 64380-199-01 and indicates it is a prescription drug (Rx only). A barcode and distributor information for Strides Pharma Inc., East Brunswick, NJ, are also shown.*
FDA Label Image

10 mg/160 mg/25 mg (30 tablets)

10 mg/160 mg/25 mg (30 tablets)
The packaging label for Amlodipine/Valsartan/Hydrochlorothiazide tablets 10 mg/160 mg/25 mg features the active ingredient strengths prominently in white text on a green background. It shows the product type as tablets, labeled for prescription use only, with a package size of 30 tablets. The label includes storage instructions and cautions, the NDC number 64380-200-01, and lists Strides Pharma Inc. as the manufacturer. A barcode and distributor information for Strides Pharma Inc., East Brunswick, NJ, are also visible.*
FDA Label Image

Image (516dd621 45ae 4fc8 8507 23d43b6d7a7e 52)

Image (516dd621 45ae 4fc8 8507 23d43b6d7a7e 52)
Label for Amlodipine/Valsartan/Hydrochlorothiazide film coated tablets showing the 10 mg/320 mg/25 mg strength. The label includes dosage instructions to see the package insert, storage conditions, a warning to keep drugs out of reach of children, and the quantity of 30 tablets. The labeler is Strides Pharma Inc., and the product is for oral use, Rx only.*

* 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.