vivitrol

Generic: naltrexone

Labeler: alkermes, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vivitrol
Generic Name naltrexone
Labeler alkermes, inc.
Dosage Form KIT
Manufacturer
Alkermes, Inc.

Identifiers & Regulatory

Product NDC 65757-300
Product ID 65757-300_0f2da087-0d96-4978-9291-4ddf836fb7e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021897
Listing Expiration 2027-12-31
Marketing Start 2006-06-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65757300
Hyphenated Format 65757-300

Supplemental Identifiers

RxCUI
637213 637216

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vivitrol (source: ndc)
Generic Name naltrexone (source: ndc)
Application Number NDA021897 (source: ndc)

Resolved Composition

Strengths
  • 5 ml
  • 380 mg
  • 337 mg
  • 4 ml
  • 3.4 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (65757-300-01) * 4 mL in 1 VIAL, GLASS (65757-302-02) * 4 mL in 1 VIAL, GLASS (65757-304-03)
source: ndc

Packages (1)

65757-300-01 1 KIT in 1 CARTON (65757-300-01) * 4 mL in 1 VIAL, GLASS (65757-302-02) * 4 mL in 1 VIAL, GLASS (65757-304-03)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

VIVITROL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "0f2da087-0d96-4978-9291-4ddf836fb7e5", "openfda": {"rxcui": ["637213", "637216"], "spl_set_id": ["cd11c435-b0f0-4bb9-ae78-60f101f3703f"], "manufacturer_name": ["Alkermes, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (65757-300-01)  *  4 mL in 1 VIAL, GLASS (65757-302-02)  *  4 mL in 1 VIAL, GLASS (65757-304-03)", "package_ndc": "65757-300-01", "marketing_start_date": "20060613"}], "brand_name": "VIVITROL", "product_id": "65757-300_0f2da087-0d96-4978-9291-4ddf836fb7e5", "dosage_form": "KIT", "product_ndc": "65757-300", "generic_name": "naltrexone", "labeler_name": "Alkermes, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIVITROL", "application_number": "NDA021897", "marketing_category": "NDA", "marketing_start_date": "20060613", "listing_expiration_date": "20271231"}