NDC 65649-551

Relistor

Methylnaltrexone Bromide

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

• Product ID: 65649-551_1357dc78-e4c6-4f46-818b-b3bf1f02ef97
• NDC: 65649-551
• Product Type: Human Prescription Drug
• Proprietary Name: Relistor
• Generic Name: Methylnaltrexone Bromide
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2008-04-24
• Marketing Category: NDA / NDA
• Application Number: NDA021964
• Labeler Name: Salix Pharmaceuticals, Inc.
• Substance Name: METHYLNALTREXONE BROMIDE
• Active Ingredient Strength: 12 mg/.6mL
• Pharm Classes: Opioid Antagonist [EPC],Opioid Antagonists [MoA],Quaternary Ammonium Compounds [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 65649-551-02

1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) > .6 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2008-04-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65649-551-02 [65649055102]

Relistor INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021964
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2008-04-24

NDC 65649-551-06 [65649055106]

Relistor INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021964
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-04-24
• Marketing End Date: 2019-03-12

NDC 65649-551-07 [65649055107]

Relistor INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021964
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2008-04-24

NDC 65649-551-03 [65649055103]

Relistor INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021964
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2008-04-24

Drug Details

Active Ingredients

Ingredient	Strength
METHYLNALTREXONE BROMIDE	12 mg/.6mL

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

65649055107 RELISTOR 12 MG/0.6 ML SYRINGE

Pricing Unit: ML | Drug Type:

65649055103 RELISTOR 12 MG/0.6 ML SYRINGE

Pricing Unit: ML | Drug Type:

65649055102 RELISTOR 12 MG/0.6 ML VIAL

Pricing Unit: ML | 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