NDC codes

FDA NDC Directory
Product NDC (as listed)69238-2794Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69238-2794Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
69238-2794-1692382794011 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

N469238279401 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under NDA 021897
ProductStrengthForm · routeLabelerProduct NDC
Vivitrolnaltrexone—KitAlkermes, Inc.65757-300
Vivitrolnaltrexone—KitAlkermes, Inc.65757-301

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in