FDA.reportPublic FDA data

Rubraca

Product NDC
82154-0785
11-digit product format
821540785
Labeler code
82154
Product ID
82154-0785_473a8026-e822-2a9e-e063-6294a90a5c06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rucaparib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
pharmaand GmbH
Application
NDA209115
Marketing category
NDA
Marketing start
2016-12-19
Substance
RUCAPARIB CAMSYLATE
Active strength
300 mg/1
Pharmacologic classes
Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rubraca
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RUCAPARIB CAMSYLATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii41AX9SJ8KO
Rxcui1862584, 1862590, 1862593, 1862595, 1921587, 1921589

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
f430e54b-e9d6-4b78-bc11-c25cef55f87cProduct name120170302

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82154-0785-1Rubraca60 in 1 BOTTLETABLET, FILM COATED6019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82154-0785-1EA - Each82154-0785b2c2ee65-dce6-4c98-b518-7a6d38b533a012024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82154-0785RUBRACA (RUCAPARIB) TABLET, FILM COATED [PHARMAAND GMBH]18Current NDC, 1 package rows20250130_0295d202-1cfe-7659-e063-6294a90a476e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1862595Rubraca 200 MG Oral TabletPSN0295d202-1cfe-7659-e063-6294a90a476e19
1921589Rubraca 250 MG Oral TabletPSN0295d202-1cfe-7659-e063-6294a90a476e19
1862590Rubraca 300 MG Oral TabletPSN0295d202-1cfe-7659-e063-6294a90a476e19
1862593rucaparib 200 MG Oral TabletPSN0295d202-1cfe-7659-e063-6294a90a476e19
1921587rucaparib 250 MG Oral TabletPSN0295d202-1cfe-7659-e063-6294a90a476e19
1862584rucaparib 300 MG Oral TabletPSN0295d202-1cfe-7659-e063-6294a90a476e19
1862595rucaparib 200 MG Oral Tablet [Rubraca]SBD0295d202-1cfe-7659-e063-6294a90a476e19
1921589rucaparib 250 MG Oral Tablet [Rubraca]SBD0295d202-1cfe-7659-e063-6294a90a476e19
1862590rucaparib 300 MG Oral Tablet [Rubraca]SBD0295d202-1cfe-7659-e063-6294a90a476e19
1862593rucaparib 200 MG Oral TabletSCD0295d202-1cfe-7659-e063-6294a90a476e19
1921587rucaparib 250 MG Oral TabletSCD0295d202-1cfe-7659-e063-6294a90a476e19
1862584rucaparib 300 MG Oral TabletSCD0295d202-1cfe-7659-e063-6294a90a476e19
1862595Rubraca (as rucaparib camisylate) 200 MG Oral TabletSY0295d202-1cfe-7659-e063-6294a90a476e19
1921589Rubraca (as rucaparib camisylate) 250 MG Oral TabletSY0295d202-1cfe-7659-e063-6294a90a476e19
1862590Rubraca (as rucaparib camisylate) 300 MG Oral TabletSY0295d202-1cfe-7659-e063-6294a90a476e19
1862595Rubraca 200 MG Oral TabletSY0295d202-1cfe-7659-e063-6294a90a476e19
1921589Rubraca 250 MG Oral TabletSY0295d202-1cfe-7659-e063-6294a90a476e19
1862590Rubraca 300 MG Oral TabletSY0295d202-1cfe-7659-e063-6294a90a476e19
1921587rucaparib (as rucaparib camisylate) 250 MG Oral TabletSY0295d202-1cfe-7659-e063-6294a90a476e19
1862593rucaparib (as rucaparib camsylate) 200 MG Oral TabletSY0295d202-1cfe-7659-e063-6294a90a476e19
1862584rucaparib (as rucaparib camsylate) 300 MG Oral TabletSY0295d202-1cfe-7659-e063-6294a90a476e19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82154-0785-18215407850160 TABLET, FILM COATED in 1 BOTTLE (82154-0785-1) 2016-12-19NoNoHistorical