VIVITROL
- Product NDC
- 65757-300
- 11-digit product format
- 657570300
- Labeler code
- 65757
- Product ID
- 65757-300_0f2da087-0d96-4978-9291-4ddf836fb7e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naltrexone
- Dosage form
- KIT
- Labeler
- Alkermes, Inc.
- Application
- NDA021897
- Marketing category
- NDA
- Marketing start
- 2006-06-13
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VIVITROL
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 637213, 637216 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65757-300-01 | VIVITROL | 1 in 1 CARTON | KIT | 1 | | 38 |
| 65757-302-02 | VIVITROL | 4 mL in 1 VIAL, GLASS | INJECTION, POWDER, FOR SUSPENSIO | 4 mL | 380 mg in 4mL | 38 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65757-300 | VIVITROL (NALTREXONE) KIT [ALKERMES, INC.] | 36 | Current NDC, Legacy NDC, 2 package rows | 20240608_cd11c435-b0f0-4bb9-ae78-60f101f3703f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65757-300-01 | 65757030001 | 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) | 1 kit | 2006-06-13 | 0000-00-00 | No | No | Current |
| 65757-302-02 | 65757030202 | 4 mL in 1 VIAL, GLASS | 4 ml | | | | | Historical |