Prescription drug · NDA
Naltrexone NDC 69238-2794
Kit · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-2794-1 | 69238279401 | 1 KIT in 1 CARTON (69238-2794-1) * 5 mL in 1 VIAL, GLASS (69238-2792-1) * 4 mL in 1 VIAL, GLASS (69238-2793-1)Marketed from May 1, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Naltrexone
- Generic name (nonproprietary)
- naltrexone
- Dosage form
- Kit
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021897
- Marketing start
- Listing expires
- Identifiers
- Product ID 69238-2794_eb09c632-ad0b-4dc9-b7a6-3189ba25f77eSPL ID eb09c632-ad0b-4dc9-b7a6-3189ba25f77eSPL set ID 6de5637f-d527-4228-af1a-3aae71155cb5RxCUI 637213
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
N469238279401followed by a unit qualifier and the quantityPackage 69238-2794-01. 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 naltrexone for extended-release injectable suspension should be part of a comprehensive management program that includes psychosocial support. Naltrexone for extended-release injectable suspension 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 naltrexone for extended-release injectable suspension. Patients should not be actively drinking at the time of initial naltrexone for extended-release injectable suspension administration (1.1) . Naltrexone for extended-release injectable suspension is indicated for the preve…
Excerpt only. Read the full label for complete information.
About NDC 69238-2794
- What is NDC 69238-2794?
- 69238-2794 is the product NDC for Naltrexone kit, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naltrexone.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Naltrexone?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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. | 65757-300 |
| Vivitrolnaltrexone | — | Kit | Alkermes, Inc. | 65757-301 |