Prescription drug · ANDA
Naltrexone Hydrochloride NDC 42291-632
Naltrexone hydrochloride 50 mg/1 · Tablet, Film coated · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-632-30 | 42291063230 | 30 TABLET, FILM COATED in 1 BOTTLE (42291-632-30)Marketed from Mar 26, 2015 | |
| 42291-632-60 | 42291063260 | 60 TABLET, FILM COATED in 1 BOTTLE (42291-632-60)Marketed from Jul 24, 2025 |
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)
- Naltrexone Hydrochloride
- Generic name (nonproprietary)
- naltrexone hydrochloride
- Active ingredients
- Naltrexone hydrochloride — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AvKARENDC labeler code 42291
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075274
- Marketing start
- Marketing end
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 42291-632_4a197f32-b382-2a52-e063-6394a90ad197SPL ID 4a197f32-b382-2a52-e063-6394a90ad197SPL set ID 21b43dab-015c-c82f-ba6e-27da0ec12fc5RxCUI 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
N442291063230followed by a unit qualifier and the quantityPackage 42291-0632-30. 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)
INDICATIONS AND USAGE Naltrexone Hydrochloride Tablets USP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone Hydrochloride Tablets USP have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.
Excerpt only. Read the full label for complete information.
About NDC 42291-632
- What is NDC 42291-632?
- 42291-632 is the product NDC for Naltrexone Hydrochloride, Naltrexone hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 2 package NDCs, 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?
- AvKARE, NDC labeler code 42291. 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 075274
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 | TAGI Pharma Inc. | 51224-206 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-008 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-023 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1047 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Elite Laboratories, Inc. | 64850-300 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0060 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals Inc. | 68071-3654 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Precision Dose Inc. | 68094-853 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Precision Dose Inc. | 68094-909 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4344 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2419 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2480 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2481 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2743 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2987 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3011 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3012 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3039 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3040 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3104 |
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