Prescription drug · ANDA
Naltrexone Hydrochloride NDC 62135-242
Naltrexone hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-242-30 | 62135024230 | 30 TABLET, FILM COATED in 1 BOTTLE (62135-242-30)Marketed from Jan 5, 2022 | |
| 62135-242-60 | 62135024260 | 60 TABLET, FILM COATED in 1 BOTTLE (62135-242-60)Marketed from Jun 11, 2024 | |
| 62135-242-90 | 62135024290 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-242-90)Marketed from Jan 5, 2022 |
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
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207905
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 62135-242_549b89e5-cdb5-6f77-e063-6394a90a58c7SPL ID 549b89e5-cdb5-6f77-e063-6394a90a58c7SPL set ID adb7c4dc-221a-4d91-9687-0d78913a92adRxCUI 1483744UNII Z6375YW9SFUPC 0362135242909, 0362135242602, 0362135242305
- 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
N462135024230followed by a unit qualifier and the quantityPackage 62135-0242-30. 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 tablets 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.
Other NDCs under ANDA 207905
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 | Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc | 23155-886 |