NDC 10144-427

AMPYRA

Dalfampridine

AMPYRA is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Acorda Therapeutics, Inc.. The primary component is Dalfampridine.

• Product ID: 10144-427_5a970cb6-fb01-1f85-e053-2a91aa0a4608
• NDC: 10144-427
• Product Type: Human Prescription Drug
• Proprietary Name: AMPYRA
• Generic Name: Dalfampridine
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2010-03-01
• Marketing Category: NDA / NDA
• Application Number: NDA022250
• Labeler Name: Acorda Therapeutics, Inc.
• Substance Name: DALFAMPRIDINE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Potassium Channel Blocker [EPC],Potassium Channel Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 10144-427-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10144-427-60)

• Marketing Start Date: 2010-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10144-427-60 [10144042760]

AMPYRA TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022250
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-03-01

Drug Details

Active Ingredients

Ingredient	Strength
DALFAMPRIDINE	10 mg/1

OpenFDA Data

• SPL SET ID: 550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783
• Manufacturer:
  • Acorda Therapeutics, Inc.
• UNII:
  • BH3B64OKL9
• RxNorm Concept Unique ID - RxCUI:
  • 897025
  • 897021
• UPC Code:
  • 0310144427602

Pharmacological Class

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

NDC Crossover Matching brand name "AMPYRA" or generic name "Dalfampridine"

NDC	Brand Name	Generic Name
10144-427	AMPYRA	Dalfampridine
0054-0479	Dalfampridine	Dalfampridine
0378-0509	dalfampridine	dalfampridine
0378-4504	dalfampridine	dalfampridine
0591-2533	Dalfampridine	Dalfampridine
16729-292	Dalfampridine	Dalfampridine
42571-275	DALFAMPRIDINE	DALFAMPRIDINE
51407-246	Dalfampridine	Dalfampridine
62756-429	Dalfampridine	Dalfampridine
63629-9450	Dalfampridine	Dalfampridine
65862-863	DALFAMPRIDINE	DALFAMPRIDINE
67877-444	Dalfampridine	Dalfampridine