NDC 65649-150

Relistor

Methylnaltrexone Bromide

Relistor is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Salix Pharmaceuticals, Inc.. The primary component is Methylnaltrexone Bromide.

• Product ID: 65649-150_1357dc78-e4c6-4f46-818b-b3bf1f02ef97
• NDC: 65649-150
• Product Type: Human Prescription Drug
• Proprietary Name: Relistor
• Generic Name: Methylnaltrexone Bromide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2008-08-01
• Marketing Category: NDA / NDA
• Application Number: NDA208271
• Labeler Name: Salix Pharmaceuticals, Inc.
• Substance Name: METHYLNALTREXONE BROMIDE
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Opioid Antagonist [EPC],Opioid Antagonists [MoA],Quaternary Ammonium Compounds [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 65649-150-06

1 BOTTLE in 1 CARTON (65649-150-06) > 6 TABLET in 1 BOTTLE

• Marketing Start Date: 2016-07-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65649-150-60 [65649015060]

Relistor TABLET

• Marketing Category: NDA
• Application Number: NDA208271
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-19
• Marketing End Date: 2017-06-30

NDC 65649-150-06 [65649015006]

Relistor TABLET

• Marketing Category: NDA
• Application Number: NDA208271
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-19

NDC 65649-150-90 [65649015090]

Relistor TABLET

• Marketing Category: NDA
• Application Number: NDA208271
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-19

Drug Details

Active Ingredients

Ingredient	Strength
METHYLNALTREXONE BROMIDE	150 mg/1

OpenFDA Data

• SPL SET ID: c488fb7c-0a5b-487c-b452-996809d1cb99
• Manufacturer:
  • Salix Pharmaceuticals, Inc.
• UNII:
  • RFO6IL3D3M
• RxNorm Concept Unique ID - RxCUI:
  • 1801519
  • 1244062
  • 1244063
  • 979115
  • 1801514
  • 979113
  • 1244064
  • 1244060

Pharmacological Class

• Opioid Antagonist [EPC]
• Opioid Antagonists [MoA]
• Quaternary Ammonium Compounds [CS]

Medicade Reported Pricing

65649015090 RELISTOR 150 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Relistor" or generic name "Methylnaltrexone Bromide"

NDC	Brand Name	Generic Name
65649-150	Relistor	Methylnaltrexone bromide
65649-551	Relistor	Methylnaltrexone bromide
65649-552	Relistor	Methylnaltrexone bromide