Talzenna

Product NDC: 63539-031
11-digit product format: 635390031
Labeler code: 63539
Product ID: 63539-031_b653221e-971f-4452-92d4-797924f1ff59
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: talazoparib
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: U.S. Pharmaceuticals
Application: NDA217439
Marketing category: NDA
Marketing start: 2024-07-09
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
Listing certified through: 2027-12-31
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
N217439-001	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07
N217439-002	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07
N217439-003	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07
N217439-004	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07
N217439-005	TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2024-03-07
N217439-006	TALZENNA	TALAZOPARIB TOSYLATE	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2024-03-07

Orange Book patents#

Current patent rows page 1 of 1 · 36 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217439-001	10780088	2029-07-27	U-3651		2024-04-05
N217439-001	8012976	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-001	8420650	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-001	9820985	2029-07-27	U-2437		2024-04-05
N217439-001	10189837	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-001	8735392	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-002	10780088	2029-07-27	U-3651		2024-04-05
N217439-002	8012976	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-002	8420650	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-002	9820985	2029-07-27	U-2437		2024-04-05
N217439-002	10189837	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-002	8735392	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-003	10780088	2029-07-27	U-3651		2024-04-05
N217439-003	8012976	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-003	8420650	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-003	9820985	2029-07-27	U-2437		2024-04-05
N217439-003	10189837	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-003	8735392	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-004	10780088	2029-07-27	U-3651		2024-04-05
N217439-004	8012976	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-004	8420650	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-004	9820985	2029-07-27	U-2437		2024-04-05
N217439-004	10189837	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-004	8735392	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-005	10780088	2029-07-27	U-3651		2024-04-05
N217439-005	8012976	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-005	8420650	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-005	9820985	2029-07-27	U-2437		2024-04-05
N217439-005	10189837	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-005	8735392	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-006	10780088	2029-07-27	U-3651		2024-04-05
N217439-006	8012976	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-006	8420650	2029-07-27		Drug substance, Drug product	2024-04-05
N217439-006	9820985	2029-07-27	U-2437		2024-04-05
N217439-006	10189837	2031-10-20		Drug substance, Drug product	2024-04-05
N217439-006	8735392	2031-10-20		Drug substance, Drug product	2024-04-05

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217439-001	I-920	2026-06-20
N217439-002	I-920	2026-06-20
N217439-004	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 3 · 96 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	N217439-001	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-002	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-003	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-004	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-005	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-006	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2024-03-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217439-001	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-002	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-003	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-004	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-005	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-006	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2024-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-001	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-002	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-003	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-004	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-005	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-006	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2024-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217439-001	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217439-002	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217439-003	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217439-004	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217439-005	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217439-006	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2024-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-001	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-002	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-003	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-004	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-005	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-006	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2024-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-001	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-002	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-003	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-004	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-005	TALZENNA	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-006	TALZENNA	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2024-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-001	TALZENNA	EQ 0.1MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-002	TALZENNA	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-003	TALZENNA	EQ 0.35MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-004	TALZENNA	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2024-03-07	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 576 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	N217439-001	10780088	2029-07-27	U-3651		2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-001	8012976	2029-07-27		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-001	8420650	2029-07-27		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-001	9820985	2029-07-27	U-2437		2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-001	10189837	2031-10-20		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-001	8735392	2031-10-20		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-002	10780088	2029-07-27	U-3651		2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-002	8012976	2029-07-27		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-002	8420650	2029-07-27		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-002	9820985	2029-07-27	U-2437		2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-002	10189837	2031-10-20		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-002	8735392	2031-10-20		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-003	10780088	2029-07-27	U-3651		2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-003	8012976	2029-07-27		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-003	8420650	2029-07-27		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-003	9820985	2029-07-27	U-2437		2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-003	10189837	2031-10-20		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-003	8735392	2031-10-20		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-004	10780088	2029-07-27	U-3651		2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-004	8012976	2029-07-27		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-004	8420650	2029-07-27		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-004	9820985	2029-07-27	U-2437		2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-004	10189837	2031-10-20		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-004	8735392	2031-10-20		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-005	10780088	2029-07-27	U-3651		2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-005	8012976	2029-07-27		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-005	8420650	2029-07-27		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-005	9820985	2029-07-27	U-2437		2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-005	10189837	2031-10-20		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-005	8735392	2031-10-20		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-006	10780088	2029-07-27	U-3651		2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-006	8012976	2029-07-27		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-006	8420650	2029-07-27		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-006	9820985	2029-07-27	U-2437		2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-006	10189837	2031-10-20		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-006	8735392	2031-10-20		Drug substance, Drug product	2024-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217439-001	10780088	2029-07-27	U-3651		2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-001	8012976	2029-07-27		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-001	8420650	2029-07-27		Drug substance, Drug product	2024-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-001	9820985	2029-07-27	U-2437		2024-04-05	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 48 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	N217439-001	I-920	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-002	I-920	2026-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217439-004	I-920	2026-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217439-001	I-920	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-002	I-920	2026-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217439-004	I-920	2026-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-001	I-920	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-002	I-920	2026-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217439-004	I-920	2026-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217439-001	I-920	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217439-002	I-920	2026-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217439-004	I-920	2026-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-001	I-920	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-002	I-920	2026-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217439-004	I-920	2026-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-001	I-920	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-002	I-920	2026-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217439-004	I-920	2026-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-001	I-920	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-002	I-920	2026-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217439-004	I-920	2026-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217439-001	I-920	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217439-002	I-920	2026-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217439-004	I-920	2026-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217439-001	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217439-002	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217439-004	I-920	2026-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217439-001	I-920	2026-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217439-002	I-920	2026-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217439-004	I-920	2026-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217439-001	I-920	2026-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217439-002	I-920	2026-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217439-004	I-920	2026-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217439-001	I-920	2026-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217439-002	I-920	2026-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217439-004	I-920	2026-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217439-001	I-920	2026-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217439-002	I-920	2026-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217439-004	I-920	2026-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217439-001	I-920	2026-06-20	`1e350fbaab3a…`

Additional Listing Data#

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

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
b653221e-971f-4452-92d4-797924f1ff59	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
63539-031-30	Talzenna	30 in 1 BOTTLE	CAPSULE, LIQUID FILLED	30		1

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	Pfizer Laboratories Div Pfizer Inc	c6fd147f-a77e-4a0b-9280-e82ecc41b4be	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217439 application number: NDA217439
Talzenna	TALAZOPARIB	U.S. Pharmaceuticals	b653221e-971f-4452-92d4-797924f1ff59	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217439 application number: NDA217439 ndc (product): 63539-031

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2591510	talazoparib 0.5 MG Oral Capsule	PSN	b653221e-971f-4452-92d4-797924f1ff59	1
2099954	talazoparib 1 MG Oral Capsule	PSN	b653221e-971f-4452-92d4-797924f1ff59	1
2591512	Talzenna 0.5 MG Oral Capsule	PSN	b653221e-971f-4452-92d4-797924f1ff59	1
2099956	Talzenna 1 MG Oral Capsule	PSN	b653221e-971f-4452-92d4-797924f1ff59	1
2591512	talazoparib 0.5 MG Oral Capsule [Talzenna]	SBD	b653221e-971f-4452-92d4-797924f1ff59	1
2099956	talazoparib 1 MG Oral Capsule [Talzenna]	SBD	b653221e-971f-4452-92d4-797924f1ff59	1
2591510	talazoparib 0.5 MG Oral Capsule	SCD	b653221e-971f-4452-92d4-797924f1ff59	1
2099954	talazoparib 1 MG Oral Capsule	SCD	b653221e-971f-4452-92d4-797924f1ff59	1
2591510	talazoparib 0.5 MG (as talazoparib tosylate 0.727 MG) Oral Capsule	SY	b653221e-971f-4452-92d4-797924f1ff59	1
2099954	talazoparib 1 MG (as talazoparib tosylate 1.453 MG) Oral Capsule	SY	b653221e-971f-4452-92d4-797924f1ff59	1
2591512	Talzenna 0.5 MG Oral Capsule	SY	b653221e-971f-4452-92d4-797924f1ff59	1
2099956	Talzenna 1 MG (as talazoparib tosylate 1.453 MG) Oral Capsule	SY	b653221e-971f-4452-92d4-797924f1ff59	1
2099956	Talzenna 1 MG Oral Capsule	SY	b653221e-971f-4452-92d4-797924f1ff59	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
63539-031-30	63539003130	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63539-031-30)	2024-07-09	No	No	Current