Aripiprazole Tablet
Product Images NDC 16729-279

21 FDA label images from Accord Healthcare, Inc. · 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 Aripiprazole (NDC 16729-279). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare, 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

10 mg-100 (10 X 10) Unit-dose Tablets (Aripiprazole 10mg 100 Tab Carton)

10 mg-100 (10 X 10) Unit-dose Tablets (Aripiprazole 10mg 100 Tab Carton)
Packaging label for Aripiprazole 10 mg Tablets, USP by Accord Healthcare, Inc. The label indicates the prescription-only oral tablet form, with a package size of 100 unit-dose tablets (10 x 10). It notes the requirement to dispense the enclosed Medication Guide to each patient. The label includes storage instructions and manufacturing details.*
FDA Label Image

10 mg-30 Tablets (Aripiprazole 10mg 30 Tab)

10 mg-30 Tablets (Aripiprazole 10mg 30 Tab)
Aripiprazole 10 mg tablets label from Accord Healthcare, Inc. The label shows the NDC number 16729-280-10, the product name Aripiprazole Tablets, USP, and the strength 10 mg. It specifies Rx Only and instructs pharmacists to dispense the enclosed Medication Guide. The package contains 30 tablets. Storage instructions and manufacturer details are also included.*
FDA Label Image

15 mg-100 (10 X 10) Unit-dose Tablets (Aripiprazole 15mg 100 Tab Carton)

15 mg-100 (10 X 10) Unit-dose Tablets (Aripiprazole 15mg 100 Tab Carton)
Packaging label for Aripiprazole tablets, USP 15 mg, oral tablet form by Accord Healthcare, Inc. The label shows the product name, strength (15 mg), prescription status (Rx Only), and instructions to dispense the enclosed Medication Guide. The package contains 100 (10 x 10) unit-dose tablets. The label also includes storage instructions, manufacturer details, and barcodes.*
FDA Label Image

15 mg-30 Tablets (Aripiprazole 15mg 30 Tab)

15 mg-30 Tablets (Aripiprazole 15mg 30 Tab)
Label for Aripiprazole Tablets USP 15 mg, manufactured and marketed by Accord Healthcare, Inc. The label states this is a prescription oral tablet with 30 tablets per package. Storage instructions recommend keeping the tablets at 25°C with allowable excursions between 15°C and 30°C. The label includes NDC 16729-281-10 and dispensing instructions for pharmacists to provide the enclosed Medication Guide. Two barcodes are visible on the label.*
FDA Label Image

20 mg-100 (10 X 10) Unit-dose Tablets (Aripiprazole 20mg 100 Tab Carton)

20 mg-100 (10 X 10) Unit-dose Tablets (Aripiprazole 20mg 100 Tab Carton)
Packaging label for Aripiprazole tablets, USP, 20 mg oral tablets by Accord Healthcare, Inc. The label indicates prescription-only status, instructs pharmacists to dispense an enclosed medication guide, and specifies a package size of 100 unit-dose tablets (10 x 10). Storage instructions and manufacturer details are also visible on the label.*
FDA Label Image

20 mg-30 Tablets (Aripiprazole 20mg 30 Tab)

20 mg-30 Tablets (Aripiprazole 20mg 30 Tab)
Label for Aripiprazole Tablets, USP 20 mg by Accord Healthcare, Inc., featuring the NDC 16729-282-10. The label includes storage instructions, manufacturer details, a medication guide URL, prescription status (Rx Only), and a package count of 30 tablets. The design includes barcode graphics and a designated blank area for lot and expiration data.*
FDA Label Image

2 mg-100 (10 X 10) Unit-dose Tablets (Aripiprazole 2mg 100 Tab Carton)

2 mg-100 (10 X 10) Unit-dose Tablets (Aripiprazole 2mg 100 Tab Carton)
Aripiprazole 2 mg oral tablets packaging label from Accord Healthcare, Inc. The label indicates the product as Aripiprazole Tablets, USP with a strength of 2 mg. It is a prescription-only medication presented in a unit-dose package containing 100 tablets (10 x 10). Storage instructions and a medication guide URL are provided. Manufacturer details include Intas Pharmaceuticals Limited, India.*
FDA Label Image

2 mg-30 Tablets (Aripiprazole 2mg 30 Tab)

2 mg-30 Tablets (Aripiprazole 2mg 30 Tab)
Label for Aripiprazole Tablets, USP 2 mg, oral tablets manufactured by Accord Healthcare, Inc. The label includes storage instructions, medication guide availability, and dispensing requirements. The package contains 30 tablets and features the NDC number 16729-278-10. Manufacturer information for Intas Pharmaceuticals Limited, India, is also included.*
FDA Label Image

30 mg-100 (10 X 10) Unit-dose Tablets (Aripiprazole 30mg 100 Tab Carton)

30 mg-100 (10 X 10) Unit-dose Tablets (Aripiprazole 30mg 100 Tab Carton)
Packaging label for Aripiprazole Tablets, USP 30 mg oral tablets. The label shows a unit-dose packaging with 100 tablets (10 x 10). It includes dispensing instructions to pharmacists and storage conditions. The labeler listed is Accord Healthcare, Inc., with manufacturing details from Intas Pharmaceuticals Limited, India.*
FDA Label Image

30 mg-30 Tablets (Aripiprazole 30mg 30 Tab)

30 mg-30 Tablets (Aripiprazole 30mg 30 Tab)
Label for Aripiprazole 30 mg tablets, USP by Accord Healthcare, Inc. This oral prescription drug label includes the NDC 16729-283-10 and states the medication is for Rx only with 30 tablets per container. Storage instructions and manufacturing details are also provided along with a purple box area reserved for overcoding lot and expiration data.*
FDA Label Image

5 mg-100 (10 X 10) Unit-dose Tablets (Aripiprazole 5mg 100 Tab Carton)

5 mg-100 (10 X 10) Unit-dose Tablets (Aripiprazole 5mg 100 Tab Carton)
Packaging label for Aripiprazole Tablets, USP 5 mg by Accord Healthcare, Inc. The label indicates this is a prescription oral tablet available in a unit-dose package of 100 tablets (10 x 10). It includes storage instructions and a barcode, with clear identification by NDC 16729-279-46. The label also advises pharmacists to dispense the enclosed Medication Guide to patients.*
FDA Label Image

5 mg-30 Tablets (Aripiprazole 5mg 30 Tab)

5 mg-30 Tablets (Aripiprazole 5mg 30 Tab)
Aripiprazole Tablets USP 5 mg oral tablets, packaged as 30 tablets per bottle. The label indicates prescription-only status and includes storage instructions, manufacturer details (Accord Healthcare for Intas Pharmaceuticals), and a medication guide link. The label contains NDC code 16729-279-10 and multiple barcodes.*
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Figure 1 (Aripiprazole Figure 1)

Figure 1 (Aripiprazole Figure 1)
A chart showing the effect of other drugs on Aripiprazole pharmacokinetics. The x-axis shows fold change relative to a reference without interacting drugs. The y-axis lists various inhibitors, inducers, acid blockers, and other drugs, with associated AUC and Cmax values depicted as points and error bars representing 90% confidence intervals.*
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Figure 2 (Aripiprazole Figure 2)

Figure 2 (Aripiprazole Figure 2)
A chart titled 'Effect of Other Drugs on Aripiprazole' showing Dehydro-Aripiprazole fold change and 90% confidence intervals. It compares the pharmacokinetic parameters AUC and Cmax for Aripiprazole when co-administered with various drugs, including CYP3A4 inhibitors (ketoconazole), CYP2D6 inhibitors (quinidine), CYP3A4 inducers (carbamazepine), gastric acid blockers (famotidine), and other drugs (valproate, lithium, lorazepam). The x-axis represents change relative to reference without interacting drug, ranging from 0.5 to 3.0.*
FDA Label Image

Figure 3 (Aripiprazole Figure 3)

Figure 3 (Aripiprazole Figure 3)
A horizontal bar chart titled 'Effect of aripiprazole on Other Drugs' showing fold changes and 90% confidence intervals for various drugs' pharmacokinetic (PK) parameters when co-administered with aripiprazole. Drugs include dextromethorphan, S-warfarin, R-warfarin, omeprazole, lamotrigine, valproate, lithium, lorazepam, venlafaxine, O-desmethylvenlafaxine, and escitalopram. The x-axis represents change relative to reference (without interacting drug) ranging from 0.5 to 3.0, with most fold changes near 1.0 indicating minimal interaction.*
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Figure 4 (Aripiprazole Figure 4)

Figure 4 (Aripiprazole Figure 4)
A chart titled 'Special Populations' that illustrates aripiprazole fold change and 90% confidence intervals in pharmacokinetic parameters AUC and Cmax. It compares groups such as CYP2D6 poor vs. extensive metabolizers, gender (female vs. male), various age ranges, hepatic impairment levels, and severe renal impairment, showing changes relative to a reference value.*
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Figure 5 (Aripiprazole Figure 5)

Figure 5 (Aripiprazole Figure 5)
A pharmacokinetic chart showing dehydro-aripiprazole fold change and 90% confidence intervals for variables including CYP2D6 metabolism status, gender, age, hepatic impairment, and severe renal impairment. The x-axis represents change relative to reference, comparing AUC and Cmax values for each factor.*
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Figure-6 (Aripiprazole Figure 6)

Figure-6 (Aripiprazole Figure 6)
A Kaplan-Meier curve comparing the proportion of subjects with relapse over time for Aripiprazole versus placebo groups. The x-axis shows days from randomization up to 182 days, and the y-axis shows the proportion with relapse from 0 to 1. The chart includes numbers of subjects at risk over time for both groups below the x-axis.*
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Figure-7 (Aripiprazole Figure 7)

Figure-7 (Aripiprazole Figure 7)
A Kaplan-Meier plot showing the proportion of subjects with relapse over 182 days from randomization for ARIPIPRAZOLE and placebo groups. The graph features two survival curves: a blue solid line for ARIPIPRAZOLE and a red dashed line for placebo, with the placebo group showing a higher relapse proportion over time. The number of subjects at risk is listed below the x-axis for both groups at various time points.*
FDA Label Image

Figure-8 (Aripiprazole Figure 8)

Figure-8 (Aripiprazole Figure 8)
A Kaplan-Meier curve chart comparing the proportion of subjects with relapse over 364 days from randomization between Aripiprazole and placebo groups. The x-axis represents days from randomization; the y-axis indicates the proportion with relapse. Two lines show Aripiprazole (solid blue) with a lower relapse proportion than placebo (dashed red). Below the x-axis, the number of subjects at risk at various time points is displayed for each group.*
FDA Label Image

Aripiprazole Chemical Structure (Aripiprazole Structure)

Aripiprazole Chemical Structure (Aripiprazole Structure)
Chemical structure of aripiprazole showing its molecular formula with chlorine-substituted aromatic rings, piperazine ring, and a complex bicyclic lactam structure.*

* 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.