NDC 62756-429

Dalfampridine

Dalfampridine

Dalfampridine is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Dalfampridine.

Product ID62756-429_418285e9-60ea-4ab7-85d0-ba85fe266b6d
NDC62756-429
Product TypeHuman Prescription Drug
Proprietary NameDalfampridine
Generic NameDalfampridine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-05-22
Marketing CategoryANDA / ANDA
Application NumberANDA208292
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameDALFAMPRIDINE
Active Ingredient Strength10 mg/1
Pharm ClassesPotassium Channel Blocker [EPC],Potassium Channel Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 62756-429-86

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-429-86)
Marketing Start Date2019-05-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62756-429-86 [62756042986]

Dalfampridine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208292
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-22

Drug Details

Active Ingredients

IngredientStrength
DALFAMPRIDINE10 mg/1

OpenFDA Data

SPL SET ID:d61e15fa-0334-49a0-ab41-c9a36b726b57
Manufacturer
UNII

Pharmacological Class

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

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

NDCBrand NameGeneric Name
0054-0479DalfampridineDalfampridine
0378-0509dalfampridinedalfampridine
0378-4504dalfampridinedalfampridine
0591-2533DalfampridineDalfampridine
16729-292DalfampridineDalfampridine
42571-275DALFAMPRIDINEDALFAMPRIDINE
51407-246DalfampridineDalfampridine
62756-429DalfampridineDalfampridine
63629-9450DalfampridineDalfampridine
65862-863DALFAMPRIDINEDALFAMPRIDINE
67877-444DalfampridineDalfampridine
10144-427AMPYRADalfampridine

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