Label: FINGOLIMOD capsule
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NDC Code(s):
70771-1603-1,
70771-1603-3,
70771-1603-7,
70771-1603-8, view more70771-1603-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 26, 2023
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INGREDIENTS AND APPEARANCE
FINGOLIMOD
fingolimod capsuleProduct 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)
