Dalfampridine: Package Insert and Label Information (Page 3 of 3)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62756-429-86
Dalfampridine Extended-release Tablets
10 mg
PHARMACIST: Dispense with Medication Guide to each patient.
Rx only
60 Tablets
SUN PHARMA

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DALFAMPRIDINE dalfampridine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-429
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DALFAMPRIDINE (DALFAMPRIDINE) DALFAMPRIDINE 10 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
POVIDONE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
TALC
ETHYLCELLULOSE, UNSPECIFIED
TRIACETIN
TITANIUM DIOXIDE
SHELLAC
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code 429
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62756-429-86 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208292 05/22/2019
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 650445203 ANALYSIS (62756-429), MANUFACTURE (62756-429)

Revised: 12/2021 Sun Pharmaceutical Industries, Inc.

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