Prescription drug · NDA
Vivitrol (Naltrexone) NDC 65757-300
Kit · Alkermes, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 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)Marketed from Jun 13, 2006 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Vivitrol
- Generic name (nonproprietary)
- naltrexone
- Dosage form
- Kit
- Labeler
- Alkermes, Inc.NDC labeler code 65757
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021897
- Marketing start
- Listing expires
- Identifiers
- Product ID 65757-300_59144e8d-9153-4f3c-8ae9-701137d4c7cdSPL ID 59144e8d-9153-4f3c-8ae9-701137d4c7cdSPL set ID cd11c435-b0f0-4bb9-ae78-60f101f3703fRxCUI 637213, 637216
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N465757030001followed by a unit qualifier and the quantityPackage 65757-0300-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support. VIVITROL contains naltrexone, an opioid antagonist, and is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration ( 1.1 ). VIVITROL is indicated for the prevention of relapse to opioid dependence, following opioid detoxification ( 1.2 ). VIVITROL should be part of a comprehensive management program that includes psychosocial support ( 1 ). 1.1 Alcohol Dependence VIVITROL is indic…
Excerpt only. Read the full label for complete information.
About NDC 65757-300
- What is NDC 65757-300?
- 65757-300 is the product NDC for Vivitrol (naltrexone) kit, listed with the FDA by Alkermes, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vivitrol (Naltrexone).
- Who is the labeler?
- Alkermes, Inc., NDC labeler code 65757. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vivitrol?
- 1 other product NDC are listed under this name. See all Vivitrol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vivitrol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vivitrolnaltrexone | — | Kit | Alkermes, Inc. | 65757-301 | 65757-0301-01 |
Other NDCs under NDA 021897
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Vivitrolnaltrexone | — | Kit | Alkermes, Inc. | 65757-301 |
| Naltrexone | — | Kit | Amneal Pharmaceuticals NY LLC | 69238-2794 |