FDA.reportPublic FDA data

ZEJULA

Product NDC
0173-0915
11-digit product format
001730915
Labeler code
0173
Product ID
0173-0915_93e60116-b3f2-4568-ae12-03d6e016a953
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
niraparib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA214876
Marketing category
NDA
Marketing start
2023-06-27
Substance
NIRAPARIB TOSYLATE
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZEJULA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIRAPARIB TOSYLATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii195Q483UZD
Rxcui2637449, 2637452, 2637465, 2640210, 2640212, 2640214

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f213b7a-23f6-497c-a54d-8a37f1798781Product name120231023
595c26ad-ded5-4c95-8cbc-96d487123743Product name120231010
98474c8b-00f8-4165-be9e-bc8fe5ad84d0Product name120170608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0173-0915-13ZEJULA30 in 1 BOTTLETABLET, FILM COATED309
0173-0915-61ZEJULA30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0915-13EA - Each0173-09156d2ce930-218b-4f29-b70b-c8ee1badf71b12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0915ZEJULA (NIRAPARIB) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]6Current NDC, 2 package rows20250327_b7f675e2-159c-490c-b6f4-3f16d9492b7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637449niraparib 100 MG Oral TabletPSNb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2637452niraparib 200 MG Oral TabletPSNb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2637465niraparib 300 MG Oral TabletPSNb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2640210Zejula 100 MG Oral TabletPSNb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2640212Zejula 200 MG Oral TabletPSNb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2640214Zejula 300 MG Oral TabletPSNb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2640210niraparib 100 MG Oral Tablet [Zejula]SBDb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2640212niraparib 200 MG Oral Tablet [Zejula]SBDb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2640214niraparib 300 MG Oral Tablet [Zejula]SBDb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2637449niraparib 100 MG Oral TabletSCDb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2637452niraparib 200 MG Oral TabletSCDb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2637465niraparib 300 MG Oral TabletSCDb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2637449niraparib 100 MG (as niraparib tosylate monohydrate 159.3 MG) Oral TabletSYb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2637452niraparib 200 MG (as niraparib tosylate monohydrate 318.7 MG) Oral TabletSYb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2637465niraparib 300 MG (as niraparib tosylate monohydrate 478 MG) Oral TabletSYb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2640210Zejula 100 MG Oral TabletSYb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2640212Zejula 200 MG Oral TabletSYb7f675e2-159c-490c-b6f4-3f16d9492b7d9
2640214Zejula 300 MG Oral TabletSYb7f675e2-159c-490c-b6f4-3f16d9492b7d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0173-0915-130017309151330 TABLET, FILM COATED in 1 BOTTLE (0173-0915-13) 2023-06-27NoNoCurrent
0173-0915-610017309156130 TABLET, FILM COATED in 1 BOTTLE (0173-0915-61) 2023-06-27YesNoCurrent