NDC Code(s) : 64980-449-03, 64980-449-28, 64980-449-07, 64980-449-97
Packager : Rising Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

fingolimodFingolimod hcl CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-449
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FINGOLIMOD HYDROCHLORIDE(UNII: G926EC510T)
(FINGOLIMOD - UNII:3QN8BYN5QF) 		FINGOLIMOD0.5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
STARCH, CORN(UNII: O8232NY3SJ)
SHELLAC(UNII: 46N107B71O)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color white (white or off-white opaque body and cap) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code S2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64980-449-0330 in 1 BOTTLE Type 0: Not a Combination Product10/04/2022
2NDC:64980-449-2828 in 1 CARTON Type 0: Not a Combination Product11/10/2021
3NDC:64980-449-077 in 1 CARTON Type 0: Not a Combination Product11/10/2021
4NDC:64980-449-977 in 1 BLISTER PACK Type 0: Not a Combination Product11/10/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207939 11/10/2021

LABELER - Rising Pharmaceuticals, Inc.(041241766)

Establishment
Name Address ID/FEI Business Operations
Sunshine Lake Pharma Co., Ltd. 545391443 manufacture(64980-449)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Package Label – 0.5 mg
Rx Only NDC64980-449-28
Fingolimod
Capsules
28 Capsules
0.5 mg
Equivalent to 0.56 mg fingolimod hydrochloride
This package contains a four-week supply of capsules.

Dispense with enclosed Medication Guide.

carton 28

PRINCIPAL DISPLAY PANEL

Package Label – 0.5 mg
Rx Only NDC 64980-449-07
Fingolimod
Capsules
7 Capsules
0.5 mg
Equivalent to 0.56 mg fingolimod hydrochloride

Dispense with enclosed Medication Guide.

carton 7

PRINCIPAL DISPLAY PANEL

Package Label – 0.5 mg

Rx Only NDC 64980-449-03

Fingolimod

Capsules

30 Capsules

0.5 mg

Equivalent to 0.56 mg fingolimod hydrochloride

Dispense with enclosed Medication Guide.

bottle label