Prescription drug · ANDA
Naltrexone Hydrochloride NDC 16729-081
Naltrexone hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Accord Healthcare, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-081-01 | 16729008101 | 100 TABLET, FILM COATED in 1 BOTTLE (16729-081-01)Marketed from Jan 18, 2012 | |
| 16729-081-10 | 16729008110 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-081-10)Marketed from Jan 18, 2012 |
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
- Accord Healthcare, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091205
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 16729-081_424db74c-6c0f-1eb3-e063-6294a90a7db8SPL ID 424db74c-6c0f-1eb3-e063-6294a90a7db8SPL set ID 49aa3d6d-2270-4615-aafa-b440859ab870RxCUI 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
N416729008101followed by a unit qualifier and the quantityPackage 16729-0081-01. 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)
INDICATIONS AND USAGE Naltrexone hydrochloride tablets USP 50 mg is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride tablets USP 50 mg 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.
Other NDCs under ANDA 091205
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 | Bryant Ranch Prepack | 71335-0014 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4925 |
| Naltrexone Hydrochloride | Naltrexone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2282 |