Rubraca

Product NDC
69660-201
11-digit product format
696600201
Labeler code
69660
Product ID
69660-201_6377c685-557e-45d5-b860-530973ca8fcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rucaparib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Clovis Oncology, Inc.
Application
NDA209115
Marketing category
NDA
Marketing start
2016-12-19
Marketing end
0000-00-00
Substance
RUCAPARIB CAMSYLATE
Active strength
200 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
69660-201-91EA - Each69660-201ba4e050b-29cf-4fdf-8eb6-a1c4f7c48fbc12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69660-201RUBRACA (RUCAPARIB) TABLET, FILM COATED [CLOVIS ONCOLOGY, INC.]14Legacy NDC20240223_a6d46c03-bb1d-417b-b8e5-3bffe352fe29.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69660-201-916966002019160 TABLET, FILM COATED in 1 BOTTLE (69660-201-91) 2016-12-190000-00-00NoNoCurrent