Vivitrol Kit
Product Images NDC 65757-300

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Vivitrol (NDC 65757-300). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alkermes, 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

Figure A (Viv03 0035 01)

The text describes the contents of a package of VIVITROL DL, an extended-release injectable suspension that contains naltrexone. The package includes a package insert, directions for use, a medication guide, a diluent for the suspension of VIVITROL Microspheres, a vial containing VIVITROL Microspheres, a prepackaged syringe, and several TERUMO administration needles of various sizes with clear needle protection devices. One TERUMO 1 inch 20G preparation needle is included for preparation purposes only and not intended for administration.*

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Figure B (Viv03 0035 02)

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Figure C (Viv03 0035 03)

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Figure D (Viv03 0035 04)

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Figure E (Viv03 0035 05)

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Figure F (Viv03 0035 06)

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Figure G (Viv03 0035 07)

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Figure H (Viv03 0035 08)

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Figure I (Viv03 0035 09)

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Figure J (Viv03 0035 10)

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Naltrexone Structural Formula (Viv03 0035 11)

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Figure 1 (Viv03 0035 12)

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Package Label- Principal Display Panel-vivitrol® Commercial Kit Carton (Viv03 0035 13)

Vivitrol is a medication in the form of an extended-release injection suspension. It needs to be diluted before administration. The carton contents should not be substituted. The medication should be stored between 2°C to 8°C. For further information, call 6003484976. The remaining text is not-readable.*

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Package Label- Principal Display Panel-vivitrol ®microspheres Vial Label (Viv03 0035 14)

NDC: 65757-302-02 is a prescription medication called Vivitrol. It contains 380 mg of Naltrexone in a single-dose vial and is designed for intramuscular injection in the gluteal region after being diluted with the enclosed diluent. Once diluted, each mL will contain 95 mg of Naltrexone. It is essential to follow the dose preparation and administration guidelines provided in the package insert. The medication requires refrigeration at 2°C to 8°C (36°F to 46°F), and any unused portions must be discarded. Vivitrol is manufactured and marketed by Alkermes, Inc., located in Waltham, MA 02451.*

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Package Label- Principal Display Panel-vivitrol® Diluent Vial Label (Viv03 0035 15)

This is a description of a diluent for use only with VIVITROL microspheres, indicated for intramuscular injection. Each 4 mL vial contains 30.0 mg carboxymethylcellulose sodium, 1.0 mg polysorbate 20, 9.0 mg sodium chloride, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The diluent is a single-dose vial and any unused portion should be discarded. The vial should not be administered directly; the package insert should be consulted for dose preparation. The diluent should be refrigerated at 2°C - 8°C and is manufactured by Alkermes, Inc. The lot number and expiration date are indicated on the label.*

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Package Label- Principal Display Panel-vivitrol® Diluent Vial Label (Viv03 0035 16)

This is the diluent that should only be used with VIVITROL microspheres, a prescription medicine. The diluent comes in a 4 mL vial, and each mL contains carboxymethylcellulose sodium, polysorbate 20, sodium chloride, and pH adjusters in water. It is a single-dose vial that needs to be refrigerated and the unused portion needs to be thrown away. The package insert has the details for dose preparation. The text also includes manufacturing and expiration details.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.