Home NDC 78206-178 Zetia
Product NDC 78206-178
11-digit product format 782060178
Labeler code 78206
Product ID 78206-178_8e5eed2a-7b64-4350-9b87-500f1b04225d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ezetimibe
Dosage form TABLET
Route ORAL
Labeler Organon LLC
Application NDA021445
Marketing category NDA
Marketing start 2021-06-01
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 2026-12-31
Current FDA listing Yes 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…
Additional Listing Data#
Finished product Yes
Brand name base Zetia
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EZETIMIBE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EOR26LQQ24 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349556 Internal RxNorm lookup 352304 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 78206-178-01 Zetia 30 in 1 BOTTLE TABLET 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-178 ZETIA (EZETIMIBE) TABLET [ORGANON LLC] 7 Current NDC, Legacy NDC, 1 package rows 20241121_174e45e0-45bb-48b7-9e60-8f6cfc1d22bb.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 78206-178-01 78206017801 30 TABLET in 1 BOTTLE (78206-178-01) 30 tablet 2021-06-01 0000-00-00 No No Current