Dalfampridine

Product NDC
0054-0479
11-digit product format
000540479
Labeler code
0054
Product ID
0054-0479_a0bb43bc-276d-4e32-bac3-7b19e78e5a4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dalfampridine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA206646
Marketing category
ANDA
Marketing start
2020-07-13
Marketing end
0000-00-00
Substance
DALFAMPRIDINE
Active strength
10 mg/1
Pharmacologic classes
Potassium Channel Blocker [EPC],Potassium Channel Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0479-21EA - Each0054-0479843b7e3d-afa6-4f52-a043-6dc695d0a0e312019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0054-0479-210005404792160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0479-21) 2020-07-130000-00-00NoNoCurrent