DALFAMPRIDINE

Product NDC
72162-2459
11-digit product format
721622459
Labeler code
72162
Product ID
72162-2459_fd48fc9a-fe75-4178-806c-ea935728cc7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DALFAMPRIDINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
72162-2459-6DALFAMPRIDINE60 in 1 BOTTLETABLET, EXTENDED RELEASE60100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2459-6EA - Each72162-24593edef4b4-c3fb-445d-a384-114aa2f433f612025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2459DALFAMPRIDINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20250214_688eb479-debc-4cfc-a74d-14828c347049.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2459-67216224590660 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2459-6) 2025-02-12NoNoCurrent