Home NDC 82804-211 Ezetimibe
Product NDC 82804-211
11-digit product format 828040211
Labeler code 82804
Product ID 82804-211_55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ezetimibe
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA078560
Marketing category ANDA
Marketing start 2022-04-29
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 A078560-001 EZETIMIBE EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078560-001 AB
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 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078560-001 EZETIMIBE 10MG TABLET / ORAL AB 2015-06-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ezetimibe
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349556 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 82804-211-30 Ezetimibe 30 in 1 BOTTLE TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-211 EZETIMIBE TABLET [PROFICIENT RX LP] 1 Current NDC, 1 package rows 20250326_55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82804-211-30 82804021130 30 TABLET in 1 BOTTLE (82804-211-30) 30 tablet 2025-03-19 No No Current