Fingolimod by Zydus Lifesciences Limited FINGOLIMOD capsule

Fingolimod by

Drug Labeling and Warnings

Fingolimod by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1603-3

Fingolimod Capsules, 0.5 mg

30 Capsules

Rx only

INGREDIENTS AND APPEARANCE

FINGOLIMOD 
fingolimod capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1603
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FINGOLIMOD HYDROCHLORIDE (UNII: G926EC510T) (FINGOLIMOD - UNII:3QN8BYN5QF)	FINGOLIMOD	0.5 mg

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE (WHITE OPAQUE BODY) , YELLOW (YELLOW OPAQUE CAP)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	16mm
Flavor		Imprint Code	912
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1603-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/11/2022
2	NDC: 70771-1603-7	1 in 1 CARTON	10/11/2022
2		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 70771-1603-8	4 in 1 CARTON	10/11/2022
3		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 70771-1603-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/11/2022
5	NDC: 70771-1603-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/11/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA207994	10/11/2022

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1603) , MANUFACTURE(70771-1603)