Home DailyMed 0bba8715-c9d9-4e95-83e9-77886c9e0ea2 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:07:43 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 84e616aacf4f…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…
Observed Orange Book patent history# Patent history page 1 of 8 · 302 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N021991-001 8093295 2026-05-16 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N021991-001 7456219 2027-03-11 Drug substance c2088c7a36db…2026-10-15 13:18:30 2026-09 N021991-001 8450372 2028-03-18 U-892 2013-06-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021991-001 8093295 2026-05-16 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021991-001 7456219 2027-03-11 Drug substance 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021991-001 8450372 2028-03-18 U-892 2013-06-14 84e616aacf4f…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…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.