FDA.reportPublic FDA data

AKEEGA

Product NDC
57894-100
11-digit product format
578940100
Labeler code
57894
Product ID
57894-100_463bff67-d7cf-a132-e063-6394a90abe1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Janssen Biotech, Inc.
Application
NDA216793
Marketing category
NDA
Marketing start
2023-08-11
Substance
ABIRATERONE ACETATE; NIRAPARIB TOSYLATE MONOHYDRATE
Active strength
500; 100 mg/1; mg/1
Pharmacologic classes
Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], 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
AKEEGA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABIRATERONE ACETATE500 mg/1
NIRAPARIB TOSYLATE MONOHYDRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEM5OCB9YJ6, 195Q483UZD
Rxcui2645244, 2645250, 2645251, 2645253

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e8e8aba9-b811-8b6a-ff1e-1aec10655d95Product name820240223
8f213b7a-23f6-497c-a54d-8a37f1798781Product name120231023
595c26ad-ded5-4c95-8cbc-96d487123743Product name120231010
fb7d5d26-0d70-42a5-a005-42898b3cfc3fProduct name120180730
98474c8b-00f8-4165-be9e-bc8fe5ad84d0Product name120170608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57894-100-60AKEEGA60 in 1 BOTTLETABLET, FILM COATED603
57894-100-60AKEEGA1 in 1 CARTONTABLET, FILM COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-100-60EA - Each57894-1007f654e8a-4ef3-4894-b7a5-b95564cec16012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-100AKEEGA (NIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATE) TABLET, FILM COATED [JANSSEN BIOTECH, INC.]2Current NDC, 2 package rows20240820_8245a990-3268-4613-b5c5-9537858a1eb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2645253Akeega 100 MG / 500 MG Oral TabletPSN8245a990-3268-4613-b5c5-9537858a1eb93
2645250Akeega 50 MG / 500 MG Oral TabletPSN8245a990-3268-4613-b5c5-9537858a1eb93
2645251niraparib 100 MG / abiraterone acetate 500 MG Oral TabletPSN8245a990-3268-4613-b5c5-9537858a1eb93
2645244niraparib 50 MG / abiraterone acetate 500 MG Oral TabletPSN8245a990-3268-4613-b5c5-9537858a1eb93
2645253abiraterone acetate 500 MG / niraparib 100 MG Oral Tablet [Akeega]SBD8245a990-3268-4613-b5c5-9537858a1eb93
2645250abiraterone acetate 500 MG / niraparib 50 MG Oral Tablet [Akeega]SBD8245a990-3268-4613-b5c5-9537858a1eb93
2645251abiraterone acetate 500 MG / niraparib 100 MG Oral TabletSCD8245a990-3268-4613-b5c5-9537858a1eb93
2645244abiraterone acetate 500 MG / niraparib 50 MG Oral TabletSCD8245a990-3268-4613-b5c5-9537858a1eb93
2645251abiraterone acetate 500 MG / niraparib 100 MG (equivalent to 153.7 MG niraparib tosylate) Oral TabletSY8245a990-3268-4613-b5c5-9537858a1eb93
2645244abiraterone acetate 500 MG / niraparib 50 MG (equivalent to 76.9 MG niraparib tosylate) Oral TabletSY8245a990-3268-4613-b5c5-9537858a1eb93
2645253Akeega (abiraterone acetate 500 MG / niraparib 100 MG (equivalent to 153.7 MG niraparib tosylate)) Oral TabletSY8245a990-3268-4613-b5c5-9537858a1eb93
2645250Akeega (abiraterone acetate 500 MG / niraparib 50 MG (equivalent to 76.9 MG niraparib tosylate)) Oral TabletSY8245a990-3268-4613-b5c5-9537858a1eb93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57894-100-60578940100601 BOTTLE in 1 CARTON (57894-100-60) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-08-11NoNoCurrent