ZEJULA

Product NDC
0173-0912
11-digit product format
001730912
Labeler code
0173
Product ID
0173-0912_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
200 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 43.

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.

Product history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-2684e616aacf4f…
2026-09-14 22:38:342026-08N214876-002ZEJULAEQ 200MG BASETABLET / ORALRLD2023-04-2684e616aacf4f…
2026-09-14 22:38:342026-08N214876-003ZEJULAEQ 300MG BASETABLET / ORALRLD, RS2023-04-2684e616aacf4f…
2026-08-18 06:07:402026-07N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07N214876-002ZEJULAEQ 200MG BASETABLET / ORALRLD2023-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07N214876-003ZEJULAEQ 300MG BASETABLET / ORALRLD, RS2023-04-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214876-002ZEJULAEQ 200MG BASETABLET / ORALRLD2023-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214876-003ZEJULAEQ 300MG BASETABLET / ORALRLD, RS2023-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214876-002ZEJULAEQ 200MG BASETABLET / ORALRLD2023-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214876-003ZEJULAEQ 300MG BASETABLET / ORALRLD, RS2023-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214876-002ZEJULAEQ 200MG BASETABLET / ORALRLD2023-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214876-003ZEJULAEQ 300MG BASETABLET / ORALRLD, RS2023-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214876-002ZEJULAEQ 200MG BASETABLET / ORALRLD2023-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214876-003ZEJULAEQ 300MG BASETABLET / ORALRLD, RS2023-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214876-002ZEJULAEQ 200MG BASETABLET / ORALRLD2023-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214876-003ZEJULAEQ 300MG BASETABLET / ORALRLD, RS2023-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214876-002ZEJULAEQ 200MG BASETABLET / ORALRLD2023-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214876-003ZEJULAEQ 300MG BASETABLET / ORALRLD, RS2023-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214876-002ZEJULAEQ 200MG BASETABLET / ORALRLD2023-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214876-003ZEJULAEQ 300MG BASETABLET / ORALRLD, RS2023-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214876-002ZEJULAEQ 200MG BASETABLET / ORALRLD2023-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214876-003ZEJULAEQ 300MG BASETABLET / ORALRLD, RS2023-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214876-002ZEJULAEQ 200MG BASETABLET / ORALRLD2023-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214876-003ZEJULAEQ 300MG BASETABLET / ORALRLD, RS2023-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N214876-002ZEJULAEQ 200MG BASETABLET / ORALRLD2023-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N214876-003ZEJULAEQ 300MG BASETABLET / ORALRLD, RS2023-04-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214876-002ZEJULAEQ 200MG BASETABLET / ORALRLD2023-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214876-003ZEJULAEQ 300MG BASETABLET / ORALRLD, RS2023-04-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214876-001ZEJULAEQ 100MG BASETABLET / ORALRLD2023-04-26301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 16 · 636 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N214876-00180715792027-08-12U-26552023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-00181432412027-08-12U-26552023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-00184361852029-04-24Drug substance2023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-00180716232031-03-27Drug substance, Drug product2023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-00188595622031-08-04U-26552023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-001110914592038-03-27Drug product2023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-001116738772038-03-27U-3646Drug product2023-07-1184e616aacf4f…
2026-09-14 22:38:342026-08N214876-001116738772038-03-27U-3647Drug product2023-07-1184e616aacf4f…
2026-09-14 22:38:342026-08N214876-001117307252039-01-25Drug product2023-09-2184e616aacf4f…
2026-09-14 22:38:342026-08N214876-00280715792027-08-12U-26552023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-00281432412027-08-12U-26552023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-00284361852029-04-24Drug substance2023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-00280716232031-03-27Drug substance, Drug product2023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-00288595622031-08-04U-26552023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-002110914592038-03-27Drug product2023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-002116738772038-03-27U-3647Drug product2023-07-1184e616aacf4f…
2026-09-14 22:38:342026-08N214876-002116738772038-03-27U-3646Drug product2023-07-1184e616aacf4f…
2026-09-14 22:38:342026-08N214876-002117307252039-01-25Drug product2023-09-2184e616aacf4f…
2026-09-14 22:38:342026-08N214876-00380715792027-08-12U-26552023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-00381432412027-08-12U-26552023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-00384361852029-04-24Drug substance2023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-00380716232031-03-27Drug substance, Drug product2023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-00388595622031-08-04U-26552023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-003110914592038-03-27Drug product2023-05-2384e616aacf4f…
2026-09-14 22:38:342026-08N214876-003116738772038-03-27U-3647Drug product2023-07-1184e616aacf4f…
2026-09-14 22:38:342026-08N214876-003116738772038-03-27U-3646Drug product2023-07-1184e616aacf4f…
2026-09-14 22:38:342026-08N214876-003117307252039-01-25Drug product2023-09-2184e616aacf4f…
2026-08-18 06:07:402026-07N214876-00180715792027-08-12U-26552023-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N214876-00181432412027-08-12U-26552023-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N214876-00184361852029-04-24Drug substance2023-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N214876-00180716232031-03-27Drug substance, Drug product2023-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N214876-00188595622031-08-04U-26552023-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N214876-001110914592038-03-27Drug product2023-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N214876-001116738772038-03-27U-3646Drug product2023-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07N214876-001116738772038-03-27U-3647Drug product2023-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07N214876-001117307252039-01-25Drug product2023-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07N214876-00280715792027-08-12U-26552023-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N214876-00281432412027-08-12U-26552023-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N214876-00284361852029-04-24Drug substance2023-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07N214876-00280716232031-03-27Drug substance, Drug product2023-05-23caaa826d4ba7…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIRAPARIB TOSYLATE200 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
0173-0912-13ZEJULA30 in 1 BOTTLETABLET, FILM COATED309
0173-0912-61ZEJULA30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0912-13EA - Each0173-0912b52a69a7-4732-4ebb-887e-a72132f9f14e12023-07-06
0173-0912-61EA - Each0173-09120f29d401-9ade-4a18-a31b-61ccba7357c712025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0912ZEJULA (NIRAPARIB) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]6Current NDC, 2 package rows20250327_b7f675e2-159c-490c-b6f4-3f16d9492b7d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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-b6f4-3f16d9492b7d2026-07-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 214876
application number: NDA214876
ndc (product): 0173-0912

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
0173-0912-130017309121330 TABLET, FILM COATED in 1 BOTTLE (0173-0912-13) 2023-06-27NoNoCurrent
0173-0912-610017309126130 TABLET, FILM COATED in 1 BOTTLE (0173-0912-61) 2023-06-27YesNoCurrent