ZEJULA

Product NDC
69656-103
11-digit product format
696560103
Labeler code
69656
Product ID
69656-103_260fc974-c8bc-44c5-8f72-b2424254c10a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
niraparib
Dosage form
CAPSULE
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA208447
Marketing category
NDA
Marketing start
2017-03-27
Marketing end
0000-00-00
Substance
NIRAPARIB
Active strength
100 mg/1
Pharmacologic classes
Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69656-103-30EA - Each69656-103a1af9cb8-660c-4a4b-b27c-65ed96c52a6212018-08-13
69656-103-90EA - Each69656-103e0e17036-a8a9-4bd2-b21c-42151d0eb3e812017-05-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69656-103-306965601033030 CAPSULE in 1 BOTTLE (69656-103-30) 30 capsule2018-07-010000-00-00NoNoCurrent
69656-103-616965601036130 CAPSULE in 1 BOTTLE (69656-103-61) 30 capsule2020-07-010000-00-00YesNoCurrent
69656-103-906965601039090 CAPSULE in 1 BOTTLE (69656-103-90) 90 capsule2017-03-270000-00-00NoNoCurrent