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

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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214876-001	ZEJULA	NIRAPARIB TOSYLATE	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26
N214876-002	ZEJULA	NIRAPARIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26
N214876-003	ZEJULA	NIRAPARIB TOSYLATE	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214876-001	8071579	2027-08-12	U-2655		2023-05-23
N214876-001	8143241	2027-08-12	U-2655		2023-05-23
N214876-001	8436185	2029-04-24		Drug substance	2023-05-23
N214876-001	8071623	2031-03-27		Drug substance, Drug product	2023-05-23
N214876-001	8859562	2031-08-04	U-2655		2023-05-23
N214876-001	11091459	2038-03-27		Drug product	2023-05-23
N214876-001	11673877	2038-03-27	U-3646	Drug product	2023-07-11
N214876-001	11673877	2038-03-27	U-3647	Drug product	2023-07-11
N214876-001	11730725	2039-01-25		Drug product	2023-09-21
N214876-002	8071579	2027-08-12	U-2655		2023-05-23
N214876-002	8143241	2027-08-12	U-2655		2023-05-23
N214876-002	8436185	2029-04-24		Drug substance	2023-05-23
N214876-002	8071623	2031-03-27		Drug substance, Drug product	2023-05-23
N214876-002	8859562	2031-08-04	U-2655		2023-05-23
N214876-002	11091459	2038-03-27		Drug product	2023-05-23
N214876-002	11673877	2038-03-27	U-3646	Drug product	2023-07-11
N214876-002	11673877	2038-03-27	U-3647	Drug product	2023-07-11
N214876-002	11730725	2039-01-25		Drug product	2023-09-21
N214876-003	8071579	2027-08-12	U-2655		2023-05-23
N214876-003	8143241	2027-08-12	U-2655		2023-05-23
N214876-003	8436185	2029-04-24		Drug substance	2023-05-23
N214876-003	8071623	2031-03-27		Drug substance, Drug product	2023-05-23
N214876-003	8859562	2031-08-04	U-2655		2023-05-23
N214876-003	11091459	2038-03-27		Drug product	2023-05-23
N214876-003	11673877	2038-03-27	U-3646	Drug product	2023-07-11
N214876-003	11673877	2038-03-27	U-3647	Drug product	2023-07-11
N214876-003	11730725	2039-01-25		Drug product	2023-09-21

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-002	ZEJULA	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-003	ZEJULA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N214876-001	8071579	2027-08-12	U-2655		2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-001	8143241	2027-08-12	U-2655		2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-001	8436185	2029-04-24		Drug substance	2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-001	8071623	2031-03-27		Drug substance, Drug product	2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-001	8859562	2031-08-04	U-2655		2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-001	11091459	2038-03-27		Drug product	2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-001	11673877	2038-03-27	U-3646	Drug product	2023-07-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-001	11673877	2038-03-27	U-3647	Drug product	2023-07-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-001	11730725	2039-01-25		Drug product	2023-09-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-002	8071579	2027-08-12	U-2655		2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-002	8143241	2027-08-12	U-2655		2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-002	8436185	2029-04-24		Drug substance	2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-002	8071623	2031-03-27		Drug substance, Drug product	2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-002	8859562	2031-08-04	U-2655		2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-002	11091459	2038-03-27		Drug product	2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-002	11673877	2038-03-27	U-3647	Drug product	2023-07-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-002	11673877	2038-03-27	U-3646	Drug product	2023-07-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-002	11730725	2039-01-25		Drug product	2023-09-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-003	8071579	2027-08-12	U-2655		2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-003	8143241	2027-08-12	U-2655		2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-003	8436185	2029-04-24		Drug substance	2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-003	8071623	2031-03-27		Drug substance, Drug product	2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-003	8859562	2031-08-04	U-2655		2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-003	11091459	2038-03-27		Drug product	2023-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-003	11673877	2038-03-27	U-3647	Drug product	2023-07-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-003	11673877	2038-03-27	U-3646	Drug product	2023-07-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214876-003	11730725	2039-01-25		Drug product	2023-09-21	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZEJULA	NIRAPARIB	GlaxoSmithKline LLC	b7f675e2-159c-490c-b6f4-3f16d9492b7d	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214876 application number: NDA214876 ndc (product): 0173-0915

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NIRAPARIB TOSYLATE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
195Q483UZD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b7f675e2-159c-490c-b6f4-3f16d9492b7d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8f213b7a-23f6-497c-a54d-8a37f1798781	Product name	1	20231023
595c26ad-ded5-4c95-8cbc-96d487123743	Product name	1	20231010
98474c8b-00f8-4165-be9e-bc8fe5ad84d0	Product name	1	20170608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0173-0915-13	ZEJULA	30 in 1 BOTTLE	TABLET, FILM COATED	30		9
0173-0915-61	ZEJULA	30 in 1 BOTTLE	TABLET, FILM COATED	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0173-0915-13	EA - Each	0173-0915	6d2ce930-218b-4f29-b70b-c8ee1badf71b	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0173-0915	ZEJULA (NIRAPARIB) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	6	Current NDC, 2 package rows	20250327_b7f675e2-159c-490c-b6f4-3f16d9492b7d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
75KE12AY9U	NIRAPARIB TOSYLATE	1038915-73-9	NIRAPARIB TOSYLATE
HMC2H89N35	NIRAPARIB	1038915-60-4	niraparib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2637449	niraparib 100 MG Oral Tablet	PSN	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2637452	niraparib 200 MG Oral Tablet	PSN	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2637465	niraparib 300 MG Oral Tablet	PSN	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2640210	Zejula 100 MG Oral Tablet	PSN	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2640212	Zejula 200 MG Oral Tablet	PSN	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2640214	Zejula 300 MG Oral Tablet	PSN	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2640210	niraparib 100 MG Oral Tablet [Zejula]	SBD	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2640212	niraparib 200 MG Oral Tablet [Zejula]	SBD	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2640214	niraparib 300 MG Oral Tablet [Zejula]	SBD	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2637449	niraparib 100 MG Oral Tablet	SCD	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2637452	niraparib 200 MG Oral Tablet	SCD	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2637465	niraparib 300 MG Oral Tablet	SCD	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2637449	niraparib 100 MG (as niraparib tosylate monohydrate 159.3 MG) Oral Tablet	SY	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2637452	niraparib 200 MG (as niraparib tosylate monohydrate 318.7 MG) Oral Tablet	SY	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2637465	niraparib 300 MG (as niraparib tosylate monohydrate 478 MG) Oral Tablet	SY	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2640210	Zejula 100 MG Oral Tablet	SY	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2640212	Zejula 200 MG Oral Tablet	SY	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9
2640214	Zejula 300 MG Oral Tablet	SY	b7f675e2-159c-490c-b6f4-3f16d9492b7d	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0173-0915-13	00173091513	30 TABLET, FILM COATED in 1 BOTTLE (0173-0915-13)	2023-06-27	No	No	Current
0173-0915-61	00173091561	30 TABLET, FILM COATED in 1 BOTTLE (0173-0915-61)	2023-06-27	Yes	No	Current