Dalfampridine

Product NDC
51407-876
11-digit product format
514070876
Labeler code
51407
Product ID
51407-876_1134ac0f-599a-a20b-e063-6294a90affcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dalfampridine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA206765
Marketing category
ANDA
Marketing start
2018-07-30
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
51407-876-60Dalfampridine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-876-60EA - Each51407-87605cf1ba9-8041-4627-9be0-60a6573938ec12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-876DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 1 package rows20240214_1134ac0f-59c1-a20b-e063-6294a90affcc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897021dalfampridine 10 MG 12HR Extended Release Oral TabletPSN1134ac0f-59c1-a20b-e063-6294a90affcc1
89702112 HR dalfampridine 10 MG Extended Release Oral TabletSCD1134ac0f-59c1-a20b-e063-6294a90affcc1
897021dalfampridine 10 MG 12 HR Extended Release Oral TabletSY1134ac0f-59c1-a20b-e063-6294a90affcc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-876-605140708766060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (51407-876-60) 2024-02-05NoNoHistorical