Vivitrol Kit
Product Images NDC 65757-301

16 FDA label images from Alkermes, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Vivitrol (NDC 65757-301). 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)

Figure A (Viv03 0035 01)
Illustration of the contents of the VIVITROL kit (naltrexone for extended-release injectable suspension) showing labeled components including a diluent vial, vial with microspheres, prepackaged syringe, two sizes of Terumo administration needles with needle protection devices, and one Terumo preparation needle not for administration. Also shown are packaged administration needles labeled 1½ inch and 2 inch.*
FDA Label Image

Figure B (Viv03 0035 02)

Figure B (Viv03 0035 02)
Illustration showing the preparation steps for the VIVITROL injection kit. It depicts hands removing a cap from a vial, attaching a needle to a syringe, and drawing medication from the vial into the syringe, indicating proper handling techniques for the injection process.*
FDA Label Image

Figure C (Viv03 0035 03)

Figure C (Viv03 0035 03)
An instructional illustration showing a person using two hands to withdraw liquid from a vial with a syringe. The image depicts the proper technique for preparing a dose from a vial, focusing on hand placement and syringe insertion into the vial's rubber stopper.*
FDA Label Image

Figure D (Viv03 0035 04)

Figure D (Viv03 0035 04)
An instructional line drawing showing a hand holding a vial with a blue cap, demonstrating the motion of rocking the vial back and forth as indicated by a double-headed arrow. The image appears to be part of handling or preparation instructions for VIVITROL kit by Alkermes, Inc.*
FDA Label Image

Figure E (Viv03 0035 05)

Figure E (Viv03 0035 05)
An instructional illustration showing the preparation of an injection for VIVITROL kit. The image depicts a hand holding a vial upside down, drawing liquid medication with a syringe needle, and highlights the vial contents with an inset close-up of the liquid inside.*
FDA Label Image

Figure F (Viv03 0035 06)

Figure F (Viv03 0035 06)
An instructional illustration labeled 'F' showing a pair of hands holding a syringe and a vial with arrows indicating a twisting motion to mix or prepare the medication. The image depicts steps for reconstituting or preparing an injectable drug dose.*
FDA Label Image

Figure G (Viv03 0035 07)

Figure G (Viv03 0035 07)
An instructional illustration showing two steps of preparing an injection syringe with a vial. One side depicts a hand inserting a vial into the syringe, and the other side shows a hand drawing liquid into the syringe. The image is likely related to the VIVITROL naltrexone kit preparation process.*
FDA Label Image

Figure H (Viv03 0035 08)

Figure H (Viv03 0035 08)
An instructional line drawing illustrating the administration of an injection into the upper outer quadrant of the buttocks. A hand holds a syringe poised for injection, with arrows indicating the direction. The patient's shorts are partially visible, outlining the recommended injection site, likely related to VIVITROL kit usage.*
FDA Label Image

Figure I (Viv03 0035 09)

Figure I (Viv03 0035 09)
Black and white instructional illustration showing a hand holding a syringe and rotating the syringe cap downward, indicating a step in preparing the injection for VIVITROL (naltrexone) kit by Alkermes, Inc.*
FDA Label Image

Figure J (Viv03 0035 10)

Figure J (Viv03 0035 10)
Black-and-white line drawing of a hand holding a syringe with a needle attached, angled downward. The syringe is filled with liquid, and the hand grips it firmly by the barrel and plunger. This instructional diagram is likely part of a medication administration guide.*
FDA Label Image

Naltrexone Structural Formula (Viv03 0035 11)

Naltrexone Structural Formula (Viv03 0035 11)
Chemical structure of naltrexone, the active ingredient in VIVITROL. The diagram shows the molecular framework with various rings, including a cyclopropylmethyl group, hydroxyl group, and ketone group, as part of the compound's structure.*
FDA Label Image

Figure 1 (Viv03 0035 12)

Figure 1 (Viv03 0035 12)
A line graph comparing the percent of patients remaining opioid-free over weeks between Vivitrol (n=126) and placebo (n=124) groups. The horizontal axis represents percent of opioid-free weeks, and the vertical axis shows the percent of patients. The Vivitrol group maintains a consistently higher percent of opioid-free patients across the weeks compared to placebo.*
FDA Label Image

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

Package Label- Principal Display Panel-vivitrol® Commercial Kit Carton (Viv03 0035 13)
Package label for VIVITROL 380 mg/vial kit, a naltrexone extended-release injectable suspension by Alkermes, Inc. The label includes storage instructions, vial contents, dosing preparation notes, and contact information for Alkermes. The design features white background with green and dark blue accents and prominently displays the VIVITROL brand name.*
FDA Label Image

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

Package Label- Principal Display Panel-vivitrol ®microspheres Vial Label (Viv03 0035 14)
VIVITROL microspheres, 380 mg/vial (naltrexone for extended-release injectable suspension) label showing single-dose vial usage instructions, dilution requirements, storage conditions, and manufacturer Alkermes, Inc. The label includes NDC 65757-302-02 and a barcode.*
FDA Label Image

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

Package Label- Principal Display Panel-vivitrol® Diluent Vial Label (Viv03 0035 15)
Label of VIVITROL kit showing the diluent vial for use with VIVITROL microspheres. The diluent volume is 4 mL per vial. It includes active components such as carboxymethylcellulose sodium, polysorbate 20, sodium chloride, and pH adjusters. Storage instructions recommend refrigeration at 2°C to 8°C (36°F to 46°F). Manufactured by Alkermes, Inc., Waltham, MA.*
FDA Label Image

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

Package Label- Principal Display Panel-vivitrol® Diluent Vial Label (Viv03 0035 16)
Diluent vial label for use with VIVITROL microspheres, containing 4 mL per vial. The label states the diluent ingredients and storage instructions, specifying refrigeration between 2°C to 8°C (36°F to 46°F). Manufactured for Alkermes, Inc. and OSO BioPharmaceuticals Mfg. The label includes NDC 65757-304-03 and 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.