Verzenio

Product NDC: 0002-5337
Requested package NDC: 0002-5337-63
11-digit product format: 000025337
Labeler code: 0002
Product ID: 0002-5337_01706851-8b56-40b8-9e22-e454b3e24f95
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: abemaciclib
Dosage form: TABLET
Route: ORAL
Labeler: Eli Lilly and Company
Application: NDA208716
Marketing category: NDA
Marketing start: 2017-09-28
Substance: ABEMACICLIB
Active strength: 150 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0002-5337	0002-5337-63	D	Discontinued by firm		2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N208716-001	VERZENIO	ABEMACICLIB	50MG	TABLET / ORAL	RLD	2017-09-28
N208716-002	VERZENIO	ABEMACICLIB	100MG	TABLET / ORAL	RLD	2017-09-28
N208716-003	VERZENIO	ABEMACICLIB	150MG	TABLET / ORAL	RLD	2017-09-28
N208716-004	VERZENIO	ABEMACICLIB	200MG	TABLET / ORAL	RLD, RS	2017-09-28

Orange Book patents#

Current patent rows page 1 of 1 · 17 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208716-001	7855211	2031-09-28	U-2135	Drug substance, Drug product	2017-10-16
N208716-001	7855211	2031-09-28	U-3242	Drug substance, Drug product	2017-10-16
N208716-001	7855211	2031-09-28	U-3265	Drug substance, Drug product	2017-10-16
N208716-001	7855211	2031-09-28	U-3546	Drug substance, Drug product	2017-10-16
N208716-002	7855211	2031-09-28	U-2135	Drug substance, Drug product	2017-10-16
N208716-002	7855211	2031-09-28	U-3242	Drug substance, Drug product	2017-10-16
N208716-002	7855211	2031-09-28	U-3265	Drug substance, Drug product	2017-10-16
N208716-002	7855211	2031-09-28	U-3546	Drug substance, Drug product	2017-10-16
N208716-003	7855211	2031-09-28	U-2135	Drug substance, Drug product	2017-10-16
N208716-003	7855211	2031-09-28	U-3242	Drug substance, Drug product	2017-10-16
N208716-003	7855211	2031-09-28	U-3265	Drug substance, Drug product	2017-10-16
N208716-003	7855211	2031-09-28	U-3546	Drug substance, Drug product	2017-10-16
N208716-004	7855211	2031-09-28	U-1981	Drug substance, Drug product	2017-10-16
N208716-004	7855211	2031-09-28	U-2135	Drug substance, Drug product	2017-10-16
N208716-004	7855211	2031-09-28	U-3242	Drug substance, Drug product	2017-10-16
N208716-004	7855211	2031-09-28	U-3265	Drug substance, Drug product	2017-10-16
N208716-004	7855211	2031-09-28	U-3546	Drug substance, Drug product	2017-10-16

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208716-001	VERZENIO	50MG	TABLET / ORAL	RLD	2017-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-002	VERZENIO	100MG	TABLET / ORAL	RLD	2017-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-003	VERZENIO	150MG	TABLET / ORAL	RLD	2017-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-004	VERZENIO	200MG	TABLET / ORAL	RLD, RS	2017-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208716-001	VERZENIO	50MG	TABLET / ORAL	RLD	2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-002	VERZENIO	100MG	TABLET / ORAL	RLD	2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-003	VERZENIO	150MG	TABLET / ORAL	RLD	2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-004	VERZENIO	200MG	TABLET / ORAL	RLD, RS	2017-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208716-001	VERZENIO	50MG	TABLET / ORAL	RLD	2017-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208716-002	VERZENIO	100MG	TABLET / ORAL	RLD	2017-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208716-003	VERZENIO	150MG	TABLET / ORAL	RLD	2017-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208716-004	VERZENIO	200MG	TABLET / ORAL	RLD, RS	2017-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208716-001	VERZENIO	50MG	TABLET / ORAL	RLD	2017-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208716-002	VERZENIO	100MG	TABLET / ORAL	RLD	2017-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208716-003	VERZENIO	150MG	TABLET / ORAL	RLD	2017-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208716-004	VERZENIO	200MG	TABLET / ORAL	RLD, RS	2017-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208716-001	VERZENIO	50MG	TABLET / ORAL	RLD	2017-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208716-002	VERZENIO	100MG	TABLET / ORAL	RLD	2017-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208716-003	VERZENIO	150MG	TABLET / ORAL	RLD	2017-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208716-004	VERZENIO	200MG	TABLET / ORAL	RLD, RS	2017-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208716-001	VERZENIO	50MG	TABLET / ORAL	RLD	2017-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208716-002	VERZENIO	100MG	TABLET / ORAL	RLD	2017-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208716-003	VERZENIO	150MG	TABLET / ORAL	RLD	2017-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208716-004	VERZENIO	200MG	TABLET / ORAL	RLD, RS	2017-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208716-001	VERZENIO	50MG	TABLET / ORAL	RLD	2017-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208716-002	VERZENIO	100MG	TABLET / ORAL	RLD	2017-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208716-003	VERZENIO	150MG	TABLET / ORAL	RLD	2017-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208716-004	VERZENIO	200MG	TABLET / ORAL	RLD, RS	2017-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208716-001	VERZENIO	50MG	TABLET / ORAL	RLD	2017-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208716-002	VERZENIO	100MG	TABLET / ORAL	RLD	2017-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208716-003	VERZENIO	150MG	TABLET / ORAL	RLD	2017-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208716-004	VERZENIO	200MG	TABLET / ORAL	RLD, RS	2017-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208716-001	VERZENIO	50MG	TABLET / ORAL	RLD	2017-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208716-002	VERZENIO	100MG	TABLET / ORAL	RLD	2017-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208716-003	VERZENIO	150MG	TABLET / ORAL	RLD	2017-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208716-004	VERZENIO	200MG	TABLET / ORAL	RLD, RS	2017-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208716-001	VERZENIO	50MG	TABLET / ORAL	RLD	2017-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208716-002	VERZENIO	100MG	TABLET / ORAL	RLD	2017-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208716-003	VERZENIO	150MG	TABLET / ORAL	RLD	2017-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208716-004	VERZENIO	200MG	TABLET / ORAL	RLD, RS	2017-09-28	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 23 · 881 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208716-001	7855211	2031-09-28	U-2135	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-001	7855211	2031-09-28	U-3546	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-001	7855211	2031-09-28	U-3265	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-001	7855211	2031-09-28	U-3242	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-002	7855211	2031-09-28	U-2135	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-002	7855211	2031-09-28	U-3546	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-002	7855211	2031-09-28	U-3265	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-002	7855211	2031-09-28	U-3242	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-003	7855211	2031-09-28	U-2135	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-003	7855211	2031-09-28	U-3546	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-003	7855211	2031-09-28	U-3265	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-003	7855211	2031-09-28	U-3242	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-004	7855211	2031-09-28	U-1981	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-004	7855211	2031-09-28	U-2135	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-004	7855211	2031-09-28	U-3265	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-004	7855211	2031-09-28	U-3546	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208716-004	7855211	2031-09-28	U-3242	Drug substance, Drug product	2017-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208716-001	7855211	2031-09-28	U-2135	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-001	7855211	2031-09-28	U-3546	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-001	7855211	2031-09-28	U-3265	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-001	7855211	2031-09-28	U-3242	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-002	7855211	2031-09-28	U-2135	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-002	7855211	2031-09-28	U-3546	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-002	7855211	2031-09-28	U-3265	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-002	7855211	2031-09-28	U-3242	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-003	7855211	2031-09-28	U-2135	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-003	7855211	2031-09-28	U-3546	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-003	7855211	2031-09-28	U-3265	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-003	7855211	2031-09-28	U-3242	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-004	7855211	2031-09-28	U-1981	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-004	7855211	2031-09-28	U-2135	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-004	7855211	2031-09-28	U-3265	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-004	7855211	2031-09-28	U-3546	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208716-004	7855211	2031-09-28	U-3242	Drug substance, Drug product	2017-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208716-001	7855211	2031-09-28	U-2135	Drug substance, Drug product	2017-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208716-001	7855211	2031-09-28	U-3546	Drug substance, Drug product	2017-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208716-001	7855211	2031-09-28	U-3265	Drug substance, Drug product	2017-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208716-001	7855211	2031-09-28	U-3242	Drug substance, Drug product	2017-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208716-002	7855211	2031-09-28	U-2135	Drug substance, Drug product	2017-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208716-002	7855211	2031-09-28	U-3546	Drug substance, Drug product	2017-10-16	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 9 · 324 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208716-001	I-877	2024-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208716-001	NPP	2024-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208716-002	I-877	2024-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208716-002	NPP	2024-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208716-003	I-877	2024-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208716-003	NPP	2024-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208716-004	I-877	2024-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208716-004	NPP	2024-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208716-001	I-877	2024-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208716-001	NPP	2024-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208716-002	I-877	2024-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208716-002	NPP	2024-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208716-003	I-877	2024-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208716-003	NPP	2024-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208716-004	I-877	2024-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208716-004	NPP	2024-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208716-001	I-877	2024-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208716-001	NPP	2024-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208716-002	I-877	2024-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208716-002	NPP	2024-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208716-003	I-877	2024-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208716-003	NPP	2024-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208716-004	I-877	2024-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208716-004	NPP	2024-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208716-001	I-877	2024-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208716-001	NPP	2024-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208716-002	I-877	2024-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208716-002	NPP	2024-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208716-003	I-877	2024-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208716-003	NPP	2024-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208716-004	I-877	2024-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208716-004	NPP	2024-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208716-001	I-877	2024-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208716-001	NPP	2024-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208716-002	I-877	2024-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208716-002	NPP	2024-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208716-003	I-877	2024-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208716-003	NPP	2024-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208716-004	I-877	2024-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208716-004	NPP	2024-10-12	`d06236e962d9…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ABEMACICLIB	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
60UAB198HK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1946830	Internal RxNorm lookup
1946836	Internal RxNorm lookup
1946838	Internal RxNorm lookup
1946840	Internal RxNorm lookup
1946842	Internal RxNorm lookup
1946844	Internal RxNorm lookup
1946846	Internal RxNorm lookup
1946848	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
be4bc0de-0fdc-4d46-8d25-be43c79e6a06	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
54b69052-dc0f-43b6-aed1-9c546fcb601c	Product name	1	20171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0002-5337-54	Verzenio	14 in 1 BLISTER PACK	TABLET	14	27
0002-5337-54	Verzenio	1 in 1 CARTON	TABLET	1	27
0002-5337-62	Verzenio	14 in 1 BLISTER PACK	TABLET	14	27
0002-5337-62	Verzenio	2 in 1 CARTON	TABLET	2	27
0002-5337-63	Verzenio	1 in 1 CARTON	TABLET	1	27
0002-5337-63	Verzenio	4 in 1 CARTON	TABLET	4	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0002-5337-54	EA - Each	0002-5337	aa15735c-3ca2-4898-b290-1f3e249fa4a1	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0002-5337	VERZENIO (ABEMACICLIB) TABLET [ELI LILLY AND COMPANY]	26	Current NDC, Legacy NDC, 6 package rows	20250309_be4bc0de-0fdc-4d46-8d25-be43c79e6a06.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Verzenio	ABEMACICLIB	Eli Lilly and Company	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208716 application number: NDA208716 ndc (package): 0002-5337-63 ndc (product): 0002-5337 ndc11 (package): 00002533763

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
60UAB198HK	ABEMACICLIB	1231929-97-7	ABEMACICLIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1946838	abemaciclib 100 MG Oral Tablet	PSN	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946842	abemaciclib 150 MG Oral Tablet	PSN	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946846	abemaciclib 200 MG Oral Tablet	PSN	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946830	abemaciclib 50 MG Oral Tablet	PSN	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946840	Verzenio 100 MG Oral Tablet	PSN	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946844	Verzenio 150 MG Oral Tablet	PSN	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946848	Verzenio 200 MG Oral Tablet	PSN	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946836	Verzenio 50 MG Oral Tablet	PSN	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946840	abemaciclib 100 MG Oral Tablet [Verzenio]	SBD	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946844	abemaciclib 150 MG Oral Tablet [Verzenio]	SBD	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946848	abemaciclib 200 MG Oral Tablet [Verzenio]	SBD	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946836	abemaciclib 50 MG Oral Tablet [Verzenio]	SBD	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946838	abemaciclib 100 MG Oral Tablet	SCD	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946842	abemaciclib 150 MG Oral Tablet	SCD	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946846	abemaciclib 200 MG Oral Tablet	SCD	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946830	abemaciclib 50 MG Oral Tablet	SCD	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946840	Verzenio 100 MG Oral Tablet	SY	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946844	Verzenio 150 MG Oral Tablet	SY	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946848	Verzenio 200 MG Oral Tablet	SY	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27
1946836	Verzenio 50 MG Oral Tablet	SY	be4bc0de-0fdc-4d46-8d25-be43c79e6a06	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0002-5337-63	00002533763	1 CARTON in 1 CARTON (0002-5337-63) / 4 BLISTER PACK in 1 CARTON / 14 TABLET in 1 BLISTER PACK	1 carton	2020-03-05	0000-00-00	Yes	No	Current