Home NDC 0002-4815 Verzenio
Product NDC 0002-4815
11-digit product format 000024815
Labeler code 0002
Product ID 0002-4815_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 100 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 100 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0002-4815-54 Verzenio 1 in 1 CARTON TABLET 1 27 0002-4815-54 Verzenio 14 in 1 BLISTER PACK TABLET 14 27 0002-4815-62 Verzenio 2 in 1 CARTON TABLET 2 27 0002-4815-62 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 0002-4815 VERZENIO (ABEMACICLIB) TABLET [ELI LILLY AND COMPANY] 26 Current NDC, Legacy NDC, 4 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.
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 0002-4815-54 00002481554 1 BLISTER PACK in 1 CARTON (0002-4815-54) / 14 TABLET in 1 BLISTER PACK 1 blister pack 2017-10-06 0000-00-00 No No Current 0002-4815-62 00002481562 2 BLISTER PACK in 1 CARTON (0002-4815-62) / 14 TABLET in 1 BLISTER PACK 2 blister pack 2025-02-15 Yes No Current