relistor

Generic: methylnaltrexone bromide

Labeler: salix pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name relistor
Generic Name methylnaltrexone bromide
Labeler salix pharmaceuticals, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

methylnaltrexone bromide 12 mg/.6mL

Manufacturer
Salix Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 65649-551
Product ID 65649-551_374e07ef-5b02-c7b3-e063-6394a90ae086
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021964
Listing Expiration 2026-12-31
Marketing Start 2008-04-24

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa] quaternary ammonium compounds [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65649551
Hyphenated Format 65649-551

Supplemental Identifiers

RxCUI
979113 979115 1244060 1244062 1244063 1244064 1801514 1801519
UNII
RFO6IL3D3M

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name relistor (source: ndc)
Generic Name methylnaltrexone bromide (source: ndc)
Application Number NDA021964 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 12 mg/.6mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE
  • 7 BLISTER PACK in 1 CARTON (65649-551-03) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE
  • 1 BLISTER PACK in 1 CARTON (65649-551-07) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE
source: ndc

Packages (3)

65649-551-02 1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE 65649-551-03 7 BLISTER PACK in 1 CARTON (65649-551-03) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE 65649-551-07 1 BLISTER PACK in 1 CARTON (65649-551-07) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE

Ingredients (1)

methylnaltrexone bromide (12 mg/.6mL)

Linked Drug Pages (1)

Relistor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "374e07ef-5b02-c7b3-e063-6394a90ae086", "openfda": {"unii": ["RFO6IL3D3M"], "rxcui": ["979113", "979115", "1244060", "1244062", "1244063", "1244064", "1801514", "1801519"], "spl_set_id": ["c488fb7c-0a5b-487c-b452-996809d1cb99"], "manufacturer_name": ["Salix Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02)  / .6 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65649-551-02", "marketing_start_date": "20080424"}, {"sample": false, "description": "7 BLISTER PACK in 1 CARTON (65649-551-03)  / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE", "package_ndc": "65649-551-03", "marketing_start_date": "20080424"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (65649-551-07)  / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE", "package_ndc": "65649-551-07", "marketing_start_date": "20080424"}], "brand_name": "Relistor", "product_id": "65649-551_374e07ef-5b02-c7b3-e063-6394a90ae086", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Quaternary Ammonium Compounds [CS]"], "product_ndc": "65649-551", "generic_name": "Methylnaltrexone bromide", "labeler_name": "Salix Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Relistor", "active_ingredients": [{"name": "METHYLNALTREXONE BROMIDE", "strength": "12 mg/.6mL"}], "application_number": "NDA021964", "marketing_category": "NDA", "marketing_start_date": "20080424", "listing_expiration_date": "20261231"}