T2017-54
For more information about RYDAPT, ask your doctor or pharmacist, visit www.US.RYDAPT.com.
This Patient Information has been approved by the U.S. Food and Drug Administration Issued: April 2017
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PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Rydapt®
(midostaurin) Capsules
NDC 0078-0698-99
25 mg
Rx only
56 soft capsules
Contents: 2 packs containing 28 capsules each
Novartis
PRINCIPAL DISPLAY PANEL
Rydapt
(midostaurin) Capsules
NDC 0078-0698-99
25 mg
Rx only
56 soft capsules
Contents: 2 packs containing 28 capsules each
Novartis
INGREDIENTS AND APPEARANCE
RYDAPT
rydapt capsule, liquid filled
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0698
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
MIDOSTAURIN (UNII: ID912S5VON) (MIDOSTAURIN - UNII:ID912S5VON) MIDOSTAURIN 25 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
CORN OIL (UNII: 8470G57WFM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CARMINIC ACID (UNII: CID8Z8N95N)
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
Color ORANGE (pale orange) Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code PKC;NVR
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0078-0698-99 2 in 1 CARTON 04/28/2017
1 NDC:0078-0698-51 14 in 1 CARTON
1 NDC:0078-0698-02 2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:0078-0698-19 4 in 1 CARTON 04/28/2017
2 NDC:0078-0698-51 14 in 1 CARTON
2 NDC:0078-0698-02 2 in 1 BLISTER PACK; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207997 04/28/2017
LABELER - NOVARTIS PHARMACEUTICALS CORPORATION (002147023)
