Home NDC 66582-414-28 Zetia
Product NDC 66582-414
Requested package NDC 66582-414-28
11-digit product format 665820414
Labeler code 66582
Product ID 66582-414_23251c26-8006-45df-b44d-c49c5882377b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ezetimibe
Dosage form TABLET
Route ORAL
Labeler Merck Sharp & Dohme Corp.
Application NDA021445
Marketing category NDA
Marketing start 2002-10-25
Marketing end 0000-00-00
Substance EZETIMIBE
Active strength 10 mg/1
Pharmacologic classes Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 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 2026-02-19 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…2022-10-28 04:53 UTC 2022-10 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021445-001 ZETIA 10MG TABLET / ORAL AB RLD, RS 2002-10-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 4 · 159 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021445-001 7612058 2025-10-30 U-1173 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021445-001 7612058 2025-10-30 U-1027 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021445-001 7612058*PED 2026-04-30 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021445-001 7612058 2025-10-30 U-1173 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021445-001 7612058 2025-10-30 U-1027 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021445-001 7612058*PED 2026-04-30 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021445-001 7612058 2025-10-30 U-1173 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021445-001 7612058 2025-10-30 U-1027 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021445-001 7612058*PED 2026-04-30 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021445-001 7612058 2025-10-30 U-1173 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021445-001 7612058 2025-10-30 U-1027 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021445-001 7612058*PED 2026-04-30 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021445-001 7612058 2025-10-30 U-1173 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021445-001 7612058 2025-10-30 U-1027 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021445-001 7612058*PED 2026-04-30 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021445-001 7612058 2025-10-30 U-1173 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021445-001 7612058 2025-10-30 U-1027 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021445-001 7612058*PED 2026-04-30 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021445-001 7612058 2025-10-30 U-1173 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021445-001 7612058 2025-10-30 U-1027 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021445-001 7612058*PED 2026-04-30 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021445-001 7612058 2025-10-30 U-1173 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021445-001 7612058 2025-10-30 U-1027 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021445-001 7612058*PED 2026-04-30 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021445-001 7612058 2025-10-30 U-1173 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021445-001 7612058 2025-10-30 U-1027 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021445-001 7612058*PED 2026-04-30 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021445-001 7612058 2025-10-30 U-1173 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021445-001 7612058 2025-10-30 U-1027 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021445-001 7612058*PED 2026-04-30 Pediatric extension d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021445-001 7612058 2025-10-30 U-1173 79d66fd596c7…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…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ezetimibe ACTIVE INGREDIENT EOR26LQQ24 ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.] 14 Ezetimibe ACTIVE MOIETY EOR26LQQ24 ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.] 14 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.] 14 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.] 14 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.] 14 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.] 14 povidones INACTIVE INGREDIENT FZ989GH94E ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.] 14 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.] 14 EZETIMIBE ACTIVE INGREDIENT EOR26LQQ24 ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 Ezetimibe ACTIVE INGREDIENT EOR26LQQ24 ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH] 2 EZETIMIBE ACTIVE MOIETY EOR26LQQ24 ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 Ezetimibe ACTIVE MOIETY EOR26LQQ24 ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH] 2 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH] 2 Ezetimibe ACTIVE INGREDIENT EOR26LQQ24 ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP] 1 Ezetimibe ACTIVE MOIETY EOR26LQQ24 ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP] 1 povidone INACTIVE INGREDIENT FZ989GH94E ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP] 1 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP] 1
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zetia EZETIMIBE Organon LLC 174e45e0-45bb-48b7-9e60-8f6cfc1d22bb 2025-11-25 Warnings, Adverse reactions Exact identifier application applno (NDA): 021445 application number: NDA021445
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 66582-414-28 66582041428 100 BLISTER PACK in 1 CARTON (66582-414-28) > 1 TABLET in 1 BLISTER PACK (66582-414-29) 100 blister pack 2002-10-25 0000-00-00 No No Current