purposes other than those listed in a Patient Information leaflet. Do not use ZEJULA for a condition for which it was not prescribed. Do not give ZEJULA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ZEJULA that is written for health professionals.
What are the ingredients in ZEJULA?
Active ingredient: niraparib
Inactive ingredients:
Capsule fill: magnesium stearate and lactose monohydrate
Capsule shell: titanium dioxide and gelatin in the white capsule body and FD&C Blue #1, FD&C Red #3, FD&C Yellow #5 and gelatin in the purple capsule cap.
The black printing ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide.
The white printing ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, sodium hydroxide, povidone and titanium oxide.
Manufactured for: TESARO, Inc. 1000 Winter St., #3300, Waltham, MA 02451
ZEJULA is a trademark of TESARO, Inc. All other trademarks referenced herein are the property of their respective owners. ©2017 TESARO, Inc. All rights reserved. 117648
For more information, call 1-844-483-7276 or go to www.tesarobio.com
PRINCIPAL DISPLAY PANEL - 100 MG CAPSULE BOTTLE LABEL
NDC 69656-103-90
Rx only
Zejula™
niraparib
capsules
100 mg
90 capsules
TESARO™
PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label
INGREDIENTS AND APPEARANCE
ZEJULA
niraparib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69656-103
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
niraparib (UNII: HMC2H89N35) (niraparib - UNII:HMC2H89N35) niraparib 100 mg
Inactive Ingredients
Ingredient Name Strength
magnesium stearate (UNII: 70097M6I30) 2.08 mg
lactose monohydrate (UNII: EWQ57Q8I5X) 254.5 mg
titanium dioxide (UNII: 15FIX9V2JP)
gelatin hydrolysate (porcine skin, mw 3000) (UNII: 0K9R94573C)
FD&C Blue no. 1 (UNII: H3R47K3TBD)
erythrosine sodium anhydrous (UNII: 8TL7LH93FM)
FD&C Yellow no. 5 (UNII: I753WB2F1M)
Product Characteristics
Color WHITE, PURPLE Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code 100;mg;Niraparib
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:69656-103-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2017
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208447 03/27/2017
LABELER - TESARO, INC. (963385559)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Charles River Laboratories Contract Mfg PA, LLC 126874135 MANUFACTURE(69656-103)
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