FDA.reportPublic FDA data

DALFAMPRIDINE

Product NDC
42571-275
11-digit product format
425710275
Labeler code
42571
Product ID
42571-275_3afc3c42-1157-b612-e063-6294a90ac179
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DALFAMPRIDINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA210158
Marketing category
ANDA
Marketing start
2019-03-21
Substance
DALFAMPRIDINE
Active strength
10 mg/1
Pharmacologic classes
Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DALFAMPRIDINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DALFAMPRIDINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBH3B64OKL9
Rxcui897021

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9109832c-cb3c-b72f-db80-0e6688f08431Product name520190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-275-05DALFAMPRIDINE500 in 1 BOTTLETABLET, EXTENDED RELEASE5009
42571-275-10DALFAMPRIDINE1000 in 1 BOTTLETABLET, EXTENDED RELEASE10009
42571-275-60DALFAMPRIDINE60 in 1 BOTTLETABLET, EXTENDED RELEASE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-275-60EA - Each42571-27521442cf8-834c-4ec7-9320-9a66c1674eeb12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-275DALFAMPRIDINE TABLET, EXTENDED RELEASE [MICRO LABS LIMITED]8Current NDC, Legacy NDC, 3 package rows20221128_302c8270-4711-4ca4-bee8-be0738fbe094.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897021dalfampridine 10 MG 12HR Extended Release Oral TabletPSN688eb479-debc-4cfc-a74d-14828c347049100
89702112 HR dalfampridine 10 MG Extended Release Oral TabletSCD688eb479-debc-4cfc-a74d-14828c347049100
897021dalfampridine 10 MG 12 HR Extended Release Oral TabletSY688eb479-debc-4cfc-a74d-14828c347049100
897021dalfampridine 10 MG 12HR Extended Release Oral TabletPSN302c8270-4711-4ca4-bee8-be0738fbe0949
89702112 HR dalfampridine 10 MG Extended Release Oral TabletSCD302c8270-4711-4ca4-bee8-be0738fbe0949
897021dalfampridine 10 MG 12 HR Extended Release Oral TabletSY302c8270-4711-4ca4-bee8-be0738fbe0949

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42571-275-0542571027505500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-05) 2019-03-210000-00-00NoNoCurrent
42571-275-10425710275101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-10) 2019-03-210000-00-00NoNoCurrent
42571-275-604257102756060 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-60) 2019-03-210000-00-00NoNoCurrent