NDC Code(s) : 67877-444-60, 67877-444-90, 67877-444-05
Packager : Ascend Laboratories, LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dalfampridine Dalfampridine TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-444
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DALFAMPRIDINE(UNII: BH3B64OKL9)
(DALFAMPRIDINE - UNII:BH3B64OKL9) 		DALFAMPRIDINE10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL (biconvex) Size 13 mm
Flavor Imprint Code D;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-444-6060 in 1 BOTTLE Type 0: Not a Combination Product31/07/2018
2NDC:67877-444-9090 in 1 BOTTLE Type 0: Not a Combination Product31/07/2018
3NDC:67877-444-05500 in 1 BOTTLE Type 0: Not a Combination Product31/07/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206765 07/31/2018

LABELER - Ascend Laboratories, LLC(141250469)

Establishment
Name Address ID/FEI Business Operations
Alkem Laboratories Limited 677605851 MANUFACTURE(67877-444)

PRINCIPAL DISPLAY PANEL

Dalfampridine Extended-release Tablets
Rx ONLY
10 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient
60 tablets
 dalfampridine-10mg-60tab