Home Applications 021445 Application 021445
Type NDA
Sponsor MSD INTL GMBH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZETIA EZETIMIBE TABLET;ORAL 10MG Yes Yes
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 N021445-001 ZETIA EZETIMIBE 10MG TABLET / ORAL AB RLD, RS 2002-10-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021445-001 AB
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 N021445-001 7612058 2025-10-30 U-1027 N021445-001 7612058 2025-10-30 U-1173 N021445-001 7612058*PED 2026-04-30 Pediatric extension
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 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Observed Orange Book patent history# Patent history page 2 of 5 · 168 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021445-001 7612058 2025-10-30 U-1027 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021445-001 7612058*PED 2026-04-30 Pediatric extension 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021445-001 7612058 2025-10-30 U-1173 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021445-001 7612058 2025-10-30 U-1027 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021445-001 7612058*PED 2026-04-30 Pediatric extension 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021445-001 7612058 2025-10-30 U-1173 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021445-001 7612058 2025-10-30 U-1027 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021445-001 7612058*PED 2026-04-30 Pediatric extension 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021445-001 7612058 2025-10-30 U-1173 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021445-001 7612058 2025-10-30 U-1027 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021445-001 7612058*PED 2026-04-30 Pediatric extension 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021445-001 7030106 2022-01-25 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021445-001 7030106*PED 2022-07-25 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021445-001 7612058 2025-10-30 U-1173 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021445-001 7612058 2025-10-30 U-1027 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021445-001 7612058*PED 2026-04-30 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021445-001 7030106 2022-01-25 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021445-001 7030106*PED 2022-07-25 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021445-001 7612058 2025-10-30 U-1173 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021445-001 7612058 2025-10-30 U-1027 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021445-001 7612058*PED 2026-04-30 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021445-001 7030106 2022-01-25 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021445-001 7030106*PED 2022-07-25 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021445-001 7612058 2025-10-30 U-1173 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021445-001 7612058 2025-10-30 U-1027 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021445-001 7612058*PED 2026-04-30 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021445-001 7030106 2022-01-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021445-001 7030106*PED 2022-07-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021445-001 7612058 2025-10-30 U-1173 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021445-001 7612058 2025-10-30 U-1027 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021445-001 7612058*PED 2026-04-30 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021445-001 7030106 2022-01-25 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021445-001 7030106*PED 2022-07-25 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021445-001 7612058 2025-10-30 U-1027 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021445-001 7612058 2025-10-30 U-1173 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021445-001 7612058*PED 2026-04-30 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021445-001 7030106 2022-01-25 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021445-001 7030106*PED 2022-07-25 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021445-001 7612058 2025-10-30 U-1173 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021445-001 7612058 2025-10-30 U-1027 782e0a99824c…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 21695-778 Zetia Ezetimibe Rebel Distributors Corp NDA Current 50090-0833 Zetia Ezetimibe A-S Medication Solutions NDA Current 55154-5031 Zetia Ezetimibe Cardinal Health NDA Current 55154-5034 Zetia Ezetimibe Cardinal Health NDA Current 55154-5043 Zetia Ezetimibe Cardinal Health NDA Current 66582-414 Zetia Ezetimibe Merck Sharp & Dohme Corp. NDA Current 66582-414 Zetia Ezetimibe Merck Sharp & Dohme Corp. NDA Current 66582-414 Zetia Ezetimibe Merck Sharp & Dohme Corp. NDA Current 66582-414 Zetia Ezetimibe Merck Sharp & Dohme Corp. NDA Current 78206-178 Zetia Ezetimibe Organon LLC NDA Current 78206-178 Zetia Ezetimibe Organon LLC NDA Current