Talzenna

Product NDC: 63539-295
11-digit product format: 635390295
Labeler code: 63539
Product ID: 63539-295_0e981f94-fca4-43e8-b88a-4b4b844f8edc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: talazoparib
Dosage form: CAPSULE
Route: ORAL
Labeler: U.S. Pharmaceuticals
Application: NDA211651
Marketing category: NDA
Marketing start: 2018-12-10
Marketing end: 2027-01-31
Substance: TALAZOPARIB TOSYLATE
Active strength: 1 mg/1
Pharmacologic classes: Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N211651-001	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16
N211651-002	TALZENNA	TALAZOPARIB TOSYLATE	EQ 1MG BASE	CAPSULE / ORAL	RLD	2018-10-16
N211651-003	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20
N211651-004	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20
N211651-005	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20
N211651-006	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20

Orange Book patents#

Current patent rows page 1 of 1 · 34 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211651-001	10780088	2029-07-27	U-3651		2023-07-19
N211651-001	8012976	2029-07-27		Drug substance, Drug product	2018-11-14
N211651-001	8420650	2029-07-27		Drug substance, Drug product	2018-11-14
N211651-001	9820985	2029-07-27	U-2437		2018-11-14
N211651-001	10189837	2031-10-20		Drug substance, Drug product	2019-02-27
N211651-001	8735392	2031-10-20		Drug substance, Drug product	2018-11-14
N211651-002	8012976	2029-07-27		Drug substance, Drug product	2018-11-14
N211651-002	8420650	2029-07-27		Drug substance, Drug product	2018-11-14
N211651-002	9820985	2029-07-27	U-2437		2018-11-14
N211651-002	10189837	2031-10-20		Drug substance, Drug product	2019-02-27
N211651-002	8735392	2031-10-20		Drug substance, Drug product	2018-11-14
N211651-003	10780088	2029-07-27	U-3651		2023-07-19
N211651-003	8012976	2029-07-27		Drug substance, Drug product	2021-10-19
N211651-003	8420650	2029-07-27		Drug substance, Drug product	2021-10-19
N211651-003	9820985	2029-07-27	U-2437		2021-10-19
N211651-003	10189837	2031-10-20		Drug substance, Drug product	2021-10-19
N211651-003	8735392	2031-10-20		Drug substance, Drug product	2021-10-19
N211651-004	8012976	2029-07-27		Drug substance, Drug product	2021-10-19
N211651-004	8420650	2029-07-27		Drug substance, Drug product	2021-10-19
N211651-004	9820985	2029-07-27	U-2437		2021-10-19
N211651-004	10189837	2031-10-20		Drug substance, Drug product	2021-10-19
N211651-004	8735392	2031-10-20		Drug substance, Drug product	2021-10-19
N211651-005	10780088	2029-07-27	U-3651		2023-07-19
N211651-005	8012976	2029-07-27		Drug substance, Drug product	2023-07-19
N211651-005	8420650	2029-07-27		Drug substance, Drug product	2023-07-19
N211651-005	9820985	2029-07-27	U-2437		2023-07-19
N211651-005	10189837	2031-10-20		Drug substance, Drug product	2023-07-19
N211651-005	8735392	2031-10-20		Drug substance, Drug product	2023-07-19
N211651-006	10780088	2029-07-27	U-3651		2023-07-19
N211651-006	8012976	2029-07-27		Drug substance, Drug product	2023-07-19
N211651-006	8420650	2029-07-27		Drug substance, Drug product	2023-07-19
N211651-006	9820985	2029-07-27	U-2437		2023-07-19
N211651-006	10189837	2031-10-20		Drug substance, Drug product	2023-07-19
N211651-006	8735392	2031-10-20		Drug substance, Drug product	2023-07-19

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211651-001	I-920	2026-06-20
N211651-003	I-920	2026-06-20
N211651-005	I-920	2026-06-20

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 5 · 194 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-006	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-005	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-006	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-005	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-006	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-005	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-006	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-005	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-006	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-005	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-006	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2023-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-001	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-002	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-003	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-004	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2021-09-20	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 27 · 1,054 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211651-001	10780088	2029-07-27	U-3651		2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-001	8012976	2029-07-27		Drug substance, Drug product	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-001	8420650	2029-07-27		Drug substance, Drug product	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-001	9820985	2029-07-27	U-2437		2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-001	10189837	2031-10-20		Drug substance, Drug product	2019-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-001	8735392	2031-10-20		Drug substance, Drug product	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-002	8012976	2029-07-27		Drug substance, Drug product	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-002	8420650	2029-07-27		Drug substance, Drug product	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-002	9820985	2029-07-27	U-2437		2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-002	10189837	2031-10-20		Drug substance, Drug product	2019-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-002	8735392	2031-10-20		Drug substance, Drug product	2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	10780088	2029-07-27	U-3651		2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	8012976	2029-07-27		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	8420650	2029-07-27		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	9820985	2029-07-27	U-2437		2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	10189837	2031-10-20		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	8735392	2031-10-20		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-004	8012976	2029-07-27		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-004	8420650	2029-07-27		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-004	9820985	2029-07-27	U-2437		2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-004	10189837	2031-10-20		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-004	8735392	2031-10-20		Drug substance, Drug product	2021-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	10780088	2029-07-27	U-3651		2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	8012976	2029-07-27		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	8420650	2029-07-27		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	9820985	2029-07-27	U-2437		2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	10189837	2031-10-20		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	8735392	2031-10-20		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-006	10780088	2029-07-27	U-3651		2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-006	8012976	2029-07-27		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-006	8420650	2029-07-27		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-006	9820985	2029-07-27	U-2437		2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-006	10189837	2031-10-20		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-006	8735392	2031-10-20		Drug substance, Drug product	2023-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211651-001	10780088	2029-07-27	U-3651		2023-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-001	8012976	2029-07-27		Drug substance, Drug product	2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-001	8420650	2029-07-27		Drug substance, Drug product	2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-001	9820985	2029-07-27	U-2437		2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-001	10189837	2031-10-20		Drug substance, Drug product	2019-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-001	8735392	2031-10-20		Drug substance, Drug product	2018-11-14	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 147 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N211651-001	I-920	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-003	I-920	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211651-005	I-920	2026-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211651-001	I-920	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-003	I-920	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211651-005	I-920	2026-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-001	I-920	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-003	I-920	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211651-005	I-920	2026-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211651-001	I-920	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-003	I-920	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211651-005	I-920	2026-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-001	I-920	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-003	I-920	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211651-005	I-920	2026-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-001	I-920	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-003	I-920	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211651-005	I-920	2026-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-001	I-920	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-003	I-920	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211651-005	I-920	2026-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211651-001	I-920	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211651-003	I-920	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211651-005	I-920	2026-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211651-001	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211651-003	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211651-005	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211651-001	I-920	2026-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211651-003	I-920	2026-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211651-005	I-920	2026-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211651-001	I-920	2026-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211651-003	I-920	2026-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211651-005	I-920	2026-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211651-001	I-920	2026-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211651-003	I-920	2026-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211651-005	I-920	2026-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211651-001	I-920	2026-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211651-003	I-920	2026-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211651-005	I-920	2026-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211651-001	I-920	2026-06-20	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Talzenna

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TALAZOPARIB TOSYLATE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
02WK9U5NZC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2099954	Internal RxNorm lookup
2099956	Internal RxNorm lookup
2591510	Internal RxNorm lookup
2591512	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
13839d4f-6acf-4ffb-a128-79df59319273	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0f22ae3e-e8f8-4cc5-86db-e9dcae189816	Product name	1	20250123
ee7ffa9d-6478-411c-a335-77574996aac2	Product name	1	20190125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63539-295-30	Talzenna	30 in 1 BOTTLE	CAPSULE	30		9
63539-295-30	Talzenna	1 in 1 CARTON	CAPSULE	1		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63539-295	TALZENNA (TALAZOPARIB) CAPSULE [U.S. PHARMACEUTICALS]	8	Current NDC, Legacy NDC, 2 package rows	20250406_13839d4f-6acf-4ffb-a128-79df59319273.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Talzenna	TALAZOPARIB	U.S. Pharmaceuticals	13839d4f-6acf-4ffb-a128-79df59319273	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211651 application number: NDA211651 ndc (product): 63539-295
Talzenna	TALAZOPARIB	Pfizer Laboratories Div Pfizer Inc	f2423edd-6d24-495c-aec1-c2f457f08d9a	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211651 application number: NDA211651

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
02WK9U5NZC	TALAZOPARIB TOSYLATE	1373431-65-2	TALAZOPARIB TOSYLATE
9QHX048FRV	TALAZOPARIB	1207456-01-6	talazoparib

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63539-295-30	63539029530	1 BOTTLE in 1 CARTON (63539-295-30) / 30 CAPSULE in 1 BOTTLE	1 bottle	2018-12-10	2027-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Talzenna	U.S. Pharmaceuticals \| Pfizer Inc \| Pharmacia & Upjohn Company LLC \| SGS Institut Fresenius GmbH \| Sharp Packaging Services, LLC	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	10