Prescription drug · NDA
Relistor (Methylnaltrexone bromide) NDC 65649-552
Methylnaltrexone bromide 8 mg/.4mL · Injection, Solution · Subcutaneous · Salix Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65649-552-04 | 6564905520465649055204 | 7 BLISTER PACK in 1 CARTON (65649-552-04) / 1 SYRINGE in 1 BLISTER PACK / .4 mL in 1 SYRINGEMarketed from Apr 24, 2008 |
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)
- Relistor
- Generic name (nonproprietary)
- methylnaltrexone bromide
- Active ingredients
- Methylnaltrexone bromide — 8 mg/.4mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Salix Pharmaceuticals, Inc.NDC labeler code 65649
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021964
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)Quaternary Ammonium Compounds (Chemical structure)
- Identifiers
- Product ID 65649-552_9db15b8c-2928-4b75-a33b-548416afc8c9SPL ID 9db15b8c-2928-4b75-a33b-548416afc8c9SPL set ID c488fb7c-0a5b-487c-b452-996809d1cb99RxCUI 979113, 979115, 1244060, 1244062, 1244063, 1244064, 1801514, 1801519UNII RFO6IL3D3M
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N465649055204followed by a unit qualifier and the quantityPackage 65649-0552-04. 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)
• RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. ( 1.1 ) • RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. ( 1.2 ) 1.1 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced co…
Excerpt only. Read the full label for complete information.
About NDC 65649-552
- What is NDC 65649-552?
- 65649-552 is the product NDC for Relistor (methylnaltrexone bromide), Methylnaltrexone bromide 8 mg/.4mL injection, solution, listed with the FDA by Salix Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Relistor (Methylnaltrexone bromide).
- What is the active ingredient?
- Methylnaltrexone bromide.
- Who is the labeler?
- Salix Pharmaceuticals, Inc., NDC labeler code 65649. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Relistor?
- 2 other product NDCs are listed under this name. See all Relistor NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Relistor products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Relistormethylnaltrexone bromide | Methylnaltrexone bromide 150 mg/1 | TabletOral | Salix Pharmaceuticals, Inc. | 65649-150 | 65649-0150-0665649-0150-90 |
| Relistormethylnaltrexone bromide | Methylnaltrexone bromide 12 mg/.6mL | Injection, SolutionSubcutaneous | Salix Pharmaceuticals, Inc. | 65649-551 | 65649-0551-0265649-0551-0365649-0551-07 |
Other NDCs under NDA 021964
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 |
|---|---|---|---|---|
| Relistormethylnaltrexone bromide | Methylnaltrexone bromide 12 mg/.6mL | Injection, SolutionSubcutaneous | Salix Pharmaceuticals, Inc. | 65649-551 |