Prescription drug · ANDA
Naltrexone Hydrochloride NDC 82804-199
Naltrexone hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-199-30 | 82804019930 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-199-30)Marketed from Feb 21, 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
- Proficient Rx LPNDC labeler code 82804
- 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 82804-199_f3305f0b-fb9e-4009-b28f-47fe9b1b618bSPL ID f3305f0b-fb9e-4009-b28f-47fe9b1b618bSPL set ID f3305f0b-fb9e-4009-b28f-47fe9b1b618bRxCUI 1483744UNII Z6375YW9SFUPC 0382804199303
- 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
N482804019930followed by a unit qualifier and the quantityPackage 82804-0199-30. 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 are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride has 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 82804-199
- What is NDC 82804-199?
- 82804-199 is the product NDC for Naltrexone Hydrochloride, Naltrexone hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. 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?
- Proficient Rx LP, NDC labeler code 82804. 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 | 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 | 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 | 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 | 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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8579 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0306 |
| 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 | Major Pharmaceuticals | 0904-7036 |