FDA.reportPublic FDA data

ZEJULA

Product NDC
0173-0909
11-digit product format
001730909
Labeler code
0173
Product ID
0173-0909_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
100 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214876-001ZEJULANIRAPARIB TOSYLATEEQ 100MG BASETABLET / ORALRLD2023-04-26
N214876-002ZEJULANIRAPARIB TOSYLATEEQ 200MG BASETABLET / ORALRLD2023-04-26
N214876-003ZEJULANIRAPARIB TOSYLATEEQ 300MG BASETABLET / ORALRLD, RS2023-04-26

Orange Book patents#

Current patent rows page 1 of 1 · 27 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214876-00180715792027-08-12U-26552023-05-23
N214876-00181432412027-08-12U-26552023-05-23
N214876-00184361852029-04-24Drug substance2023-05-23
N214876-00180716232031-03-27Drug substance, Drug product2023-05-23
N214876-00188595622031-08-04U-26552023-05-23
N214876-001110914592038-03-27Drug product2023-05-23
N214876-001116738772038-03-27U-3646Drug product2023-07-11
N214876-001116738772038-03-27U-3647Drug product2023-07-11
N214876-001117307252039-01-25Drug product2023-09-21
N214876-00280715792027-08-12U-26552023-05-23
N214876-00281432412027-08-12U-26552023-05-23
N214876-00284361852029-04-24Drug substance2023-05-23
N214876-00280716232031-03-27Drug substance, Drug product2023-05-23
N214876-00288595622031-08-04U-26552023-05-23
N214876-002110914592038-03-27Drug product2023-05-23
N214876-002116738772038-03-27U-3646Drug product2023-07-11
N214876-002116738772038-03-27U-3647Drug product2023-07-11
N214876-002117307252039-01-25Drug product2023-09-21
N214876-00380715792027-08-12U-26552023-05-23
N214876-00381432412027-08-12U-26552023-05-23
N214876-00384361852029-04-24Drug substance2023-05-23
N214876-00380716232031-03-27Drug substance, Drug product2023-05-23
N214876-00388595622031-08-04U-26552023-05-23
N214876-003110914592038-03-27Drug product2023-05-23
N214876-003116738772038-03-27U-3646Drug product2023-07-11
N214876-003116738772038-03-27U-3647Drug product2023-07-11
N214876-003117307252039-01-25Drug product2023-09-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-26a50c72e98297…
2026-08-01 22:54:322026-06N214876-002ZEJULAEQ 200MG BASETABLET / ORALRLD2023-04-26a50c72e98297…
2026-08-01 22:54:322026-06N214876-003ZEJULAEQ 300MG BASETABLET / ORALRLD, RS2023-04-26a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N214876-00180715792027-08-12U-26552023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-00181432412027-08-12U-26552023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-00184361852029-04-24Drug substance2023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-00180716232031-03-27Drug substance, Drug product2023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-00188595622031-08-04U-26552023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-001110914592038-03-27Drug product2023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-001116738772038-03-27U-3646Drug product2023-07-11a50c72e98297…
2026-08-01 22:54:322026-06N214876-001116738772038-03-27U-3647Drug product2023-07-11a50c72e98297…
2026-08-01 22:54:322026-06N214876-001117307252039-01-25Drug product2023-09-21a50c72e98297…
2026-08-01 22:54:322026-06N214876-00280715792027-08-12U-26552023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-00281432412027-08-12U-26552023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-00284361852029-04-24Drug substance2023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-00280716232031-03-27Drug substance, Drug product2023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-00288595622031-08-04U-26552023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-002110914592038-03-27Drug product2023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-002116738772038-03-27U-3647Drug product2023-07-11a50c72e98297…
2026-08-01 22:54:322026-06N214876-002116738772038-03-27U-3646Drug product2023-07-11a50c72e98297…
2026-08-01 22:54:322026-06N214876-002117307252039-01-25Drug product2023-09-21a50c72e98297…
2026-08-01 22:54:322026-06N214876-00380715792027-08-12U-26552023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-00381432412027-08-12U-26552023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-00384361852029-04-24Drug substance2023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-00380716232031-03-27Drug substance, Drug product2023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-00388595622031-08-04U-26552023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-003110914592038-03-27Drug product2023-05-23a50c72e98297…
2026-08-01 22:54:322026-06N214876-003116738772038-03-27U-3647Drug product2023-07-11a50c72e98297…
2026-08-01 22:54:322026-06N214876-003116738772038-03-27U-3646Drug product2023-07-11a50c72e98297…
2026-08-01 22:54:322026-06N214876-003117307252039-01-25Drug product2023-09-21a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZEJULANIRAPARIBGlaxoSmithKline LLCb7f675e2-159c-490c-b6f4-3f16d9492b7d2026-03-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 214876
application number: NDA214876
ndc (product): 0173-0909

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIRAPARIB TOSYLATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
195Q483UZDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2637449Internal RxNorm lookup
2637452Internal RxNorm lookup
2637465Internal RxNorm lookup
2640210Internal RxNorm lookup
2640212Internal RxNorm lookup
2640214Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b7f675e2-159c-490c-b6f4-3f16d9492b7dAvailable on FDA.report

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
0173-0909-13ZEJULA30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0909-13EA - Each0173-0909252c0a2d-b520-426d-a178-92937538ab6112023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0909ZEJULA (NIRAPARIB) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]6Current NDC, 1 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
0173-0909-130017309091330 TABLET, FILM COATED in 1 BOTTLE (0173-0909-13) 2023-06-27NoNoCurrent