Prescription drug · ANDA
Naltrexone Hydrochloride NDC 0615-8579
Naltrexone hydrochloride 50 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8579-39 | 00615857939 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8579-39)Marketed from Aug 27, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Naltrexone Hydrochloride
- Generic name (nonproprietary)
- naltrexone hydrochloride
- Active ingredients
- Naltrexone hydrochloride — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090356
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 0615-8579_cdb406b8-353a-42e0-be3d-076d2d789ddcSPL ID cdb406b8-353a-42e0-be3d-076d2d789ddcSPL set ID fa2f842f-001a-4f1e-8748-c7852579109cRxCUI 1483744UNII Z6375YW9SF
- Pharmacologic class
- Opioid Antagonist
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400615857939followed by a unit qualifier and the quantityPackage 00615-8579-39. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 0615-8579
- What is NDC 0615-8579?
- 0615-8579 is the product NDC for Naltrexone Hydrochloride, Naltrexone hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naltrexone Hydrochloride.
- What is the active ingredient?
- Naltrexone hydrochloride.
- Who is the labeler?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 Hydrochloride?
- 44 other product NDCs are listed under this name. See all Naltrexone Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naltrexone Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0306 | 67046-0306-03 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0060 | 67046-0060-03 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-023 | 53401-0023-3053401-0023-3153401-0023-53 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Elite Laboratories, Inc. | 64850-300 | 64850-0300-0164850-0300-30 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3011 | 71335-3011-01 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3012 | 71335-3012-01 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3039 | 71335-3039-01 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3040 | 71335-3040-01 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2529 | 72162-2529-0172162-2529-03 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4344 | 70518-4344-00 |
Other NDCs under ANDA 090356
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 |
|---|---|---|---|---|
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7036 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-326 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0306 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2718 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2062 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-199 |