FINGOLIMOD- fingolimod capsule 
Zydus Lifesciences Limited

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Fingolimod Capsules

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1603-3

Fingolimod Capsules, 0.5 mg

30 Capsules

Rx only

fingo label
FINGOLIMOD 
fingolimod capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1603
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FINGOLIMOD HYDROCHLORIDE (UNII: G926EC510T) (FINGOLIMOD - UNII:3QN8BYN5QF) FINGOLIMOD0.5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE OPAQUE BODY) , YELLOW (YELLOW OPAQUE CAP) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code 912
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1603-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/11/2022
2NDC:70771-1603-71 in 1 CARTON10/11/2022
27 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:70771-1603-84 in 1 CARTON10/11/2022
37 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:70771-1603-330 in 1 BOTTLE; Type 0: Not a Combination Product10/11/2022
5NDC:70771-1603-990 in 1 BOTTLE; Type 0: Not a Combination Product10/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20799410/11/2022
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1603) , MANUFACTURE(70771-1603)

Revised: 9/2023
Document Id: 70276094-fd55-497a-bd17-fab2d24eae9a
Set id: 5a0319b4-4bc6-4564-9687-9cfd5c1b23a8
Version: 4
Effective Time: 20230926
 
Zydus Lifesciences Limited