Relistor (methylnaltrexone bromide) NDC 65649-552

NDC codes

FDA NDC Directory

Product NDC (as listed)65649-552Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65649-0552Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65649-552-04	65649055204	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.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021964
Marketing start: Apr 24, 2008
Listing expires: Dec 31, 2027
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.

How CPT relates to drug billing

NDC on a medical claim

N465649055204 followed by a unit qualifier and the quantity

Package 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 May 1, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021964

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021964
Product	Strength	Form · route	Labeler	Product NDC
Relistormethylnaltrexone bromide	Methylnaltrexone bromide 12 mg/.6mL	Injection, SolutionSubcutaneous	Salix Pharmaceuticals, Inc.	65649-551