NDC 49938-110

Ruzurgi

Amifampridine

Ruzurgi is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Jacobus Pharmaceutical Company,inc. The primary component is Amifampridine.

• Product ID: 49938-110_0fca1a28-6f92-48ce-9c22-98e40a6b9a6b
• NDC: 49938-110
• Product Type: Human Prescription Drug
• Proprietary Name: Ruzurgi
• Generic Name: Amifampridine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-07-02
• Marketing Category: NDA / NDA
• Application Number: NDA209321
• Labeler Name: Jacobus Pharmaceutical Company,Inc
• Substance Name: AMIFAMPRIDINE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Potassium Channel Blocker [EPC],Potassium Channel Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 49938-110-01

1 BOTTLE, PLASTIC in 1 CARTON (49938-110-01) > 100 TABLET in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2019-07-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49938-110-01 [49938011001]

Ruzurgi TABLET

• Marketing Category: NDA
• Application Number: NDA209321
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-07-02

Drug Details

Active Ingredients

Ingredient	Strength
AMIFAMPRIDINE	10 mg/1

OpenFDA Data

• SPL SET ID: 2731310a-c060-4d3e-ba41-763d791f63a9
• Manufacturer:
  • Jacobus Pharmaceutical Company, Inc.
• UNII:
  • RU4S6E2G0J
• RxNorm Concept Unique ID - RxCUI:
  • 2106343
  • 2174818
• UPC Code:
  • 0349938110017

Pharmacological Class

• Potassium Channel Blocker [EPC]
• Potassium Channel Antagonists [MoA]