NDC 42571-275

DALFAMPRIDINE

Dalfampridine

DALFAMPRIDINE is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Micro Labs Limited. The primary component is Dalfampridine.

Product ID42571-275_83d234fd-bdfa-b646-e053-2a91aa0a3b12
NDC42571-275
Product TypeHuman Prescription Drug
Proprietary NameDALFAMPRIDINE
Generic NameDalfampridine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-03-21
Marketing CategoryANDA / ANDA
Application NumberANDA210158
Labeler NameMicro Labs Limited
Substance NameDALFAMPRIDINE
Active Ingredient Strength10 mg/1
Pharm ClassesPotassium Channel Blocker [EPC],Potassium Channel Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42571-275-05

500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-05)
Marketing Start Date2019-03-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42571-275-60 [42571027560]

DALFAMPRIDINE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210158
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-21

NDC 42571-275-05 [42571027505]

DALFAMPRIDINE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210158
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-21

NDC 42571-275-10 [42571027510]

DALFAMPRIDINE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210158
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-21

Drug Details

Active Ingredients

IngredientStrength
DALFAMPRIDINE10 mg/1

OpenFDA Data

SPL SET ID:302c8270-4711-4ca4-bee8-be0738fbe094
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 897021
    • UPC Code
  • 0342571275600

    • 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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