Home NDC 0002-6216 Verzenio
Product NDC 0002-6216
11-digit product format 000026216
Labeler code 0002
Product ID 0002-6216_02db1b7f-c6fc-4f7c-96d3-8ab9b8b97068
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 200 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Kinase 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes 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 Product TE source text 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.
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 200 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0002-6216-54 Verzenio 1 in 1 CARTON TABLET 1 27 0002-6216-54 Verzenio 14 in 1 BLISTER PACK TABLET 14 27
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0002-6216 VERZENIO (ABEMACICLIB) TABLET [ELI LILLY AND COMPANY] 26 Current NDC, Legacy NDC, 2 package rows 20250309_be4bc0de-0fdc-4d46-8d25-be43c79e6a06.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0002-6216-54 00002621654 1 BLISTER PACK in 1 CARTON (0002-6216-54) / 14 TABLET in 1 BLISTER PACK 1 blister pack 2017-10-06 0000-00-00 No No Current