Home NDC 0006-0568 ZOLINZA
Product NDC 0006-0568
11-digit product format 000060568
Labeler code 0006
Product ID 0006-0568_27d99e44-bbc6-445d-b08b-e32fd8702dc3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vorinostat
Dosage form CAPSULE
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application NDA021991
Marketing category NDA
Marketing start 2006-10-06
Substance VORINOSTAT
Active strength 100 mg/1
Pharmacologic classes Histone Deacetylase Inhibitor [EPC], Histone Deacetylase 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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021991-001 ZOLINZA VORINOSTAT 100MG CAPSULE / ORAL RLD, RS 2006-10-06
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021991-001 8093295 2026-05-16 Drug product N021991-001 7456219 2027-03-11 Drug substance N021991-001 8450372 2028-03-18 U-892 2013-06-14
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 2 · 42 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 2026-08-18 06:07:40 2026-07 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 8 · 296 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 N021991-001 8093295 2026-05-16 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021991-001 7456219 2027-03-11 Drug substance caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021991-001 8450372 2028-03-18 U-892 2013-06-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021991-001 8093295 2026-05-16 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021991-001 7456219 2027-03-11 Drug substance 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021991-001 8450372 2028-03-18 U-892 2013-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021991-001 7399787 2025-02-09 U-892 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021991-001 8093295 2026-05-16 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021991-001 7456219 2027-03-11 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021991-001 8450372 2028-03-18 U-892 2013-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021991-001 7399787 2025-02-09 U-892 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021991-001 8093295 2026-05-16 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021991-001 7456219 2027-03-11 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021991-001 8450372 2028-03-18 U-892 2013-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021991-001 7399787 2025-02-09 U-892 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021991-001 8093295 2026-05-16 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021991-001 7456219 2027-03-11 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021991-001 8450372 2028-03-18 U-892 2013-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021991-001 7399787 2025-02-09 U-892 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021991-001 8093295 2026-05-16 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021991-001 7456219 2027-03-11 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021991-001 8450372 2028-03-18 U-892 2013-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021991-001 7851509 2024-02-21 U-892 Drug product 2010-12-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021991-001 7399787 2025-02-09 U-892 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021991-001 8093295 2026-05-16 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021991-001 7456219 2027-03-11 Drug substance 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021991-001 8450372 2028-03-18 U-892 2013-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021991-001 7851509 2024-02-21 U-892 Drug product 2010-12-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021991-001 7399787 2025-02-09 U-892 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021991-001 8093295 2026-05-16 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021991-001 7456219 2027-03-11 Drug substance 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021991-001 8450372 2028-03-18 U-892 2013-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021991-001 7851509 2024-02-21 U-892 Drug product 2010-12-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021991-001 7399787 2025-02-09 U-892 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021991-001 8093295 2026-05-16 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021991-001 7456219 2027-03-11 Drug substance 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021991-001 8450372 2028-03-18 U-892 2013-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021991-001 7851509 2024-02-21 U-892 Drug product 2010-12-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021991-001 7399787 2025-02-09 U-892 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021991-001 8093295 2026-05-16 Drug product d8e5a09893c0…
Additional Listing Data#
Finished product Yes
Brand name base ZOLINZA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VORINOSTAT 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 58IFB293JI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 668579 Internal RxNorm lookup 668606 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 0006-0568-40 ZOLINZA 120 in 1 BOTTLE CAPSULE 120 27
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-0568 ZOLINZA (VORINOSTAT) CAPSULE [MERCK SHARP & DOHME LLC] 26 Current NDC, Legacy NDC, 1 package rows 20241129_cd86ee78-2781-468b-930c-3c4677bcc092.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 0006-0568-40 00006056840 120 CAPSULE in 1 BOTTLE (0006-0568-40) 120 capsule 2006-10-06 0000-00-00 No No Current