Home NDC 71335-0933-4 Ezetimibe
Product NDC 71335-0933
Requested package NDC 71335-0933-4
11-digit product format 713350933
Labeler code 71335
Product ID 71335-0933_4b23230f-2852-4daa-a5d8-45b5da0fb63e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ezetimibe
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA200831
Marketing category ANDA
Marketing start 2017-06-12
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 71335-0933 71335-0933-4 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 71335-0933 71335-0933-4 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 A200831-001 EZETIMIBE EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200831-001 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 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200831-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-0933-1 2024-05-15 These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002 71335-0933-2 2024-05-15 These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002 71335-0933-3 2024-05-15 These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002 71335-0933-4 2024-05-15 These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002 71335-0933-5 2024-05-15 These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002 71335-0933-1 2024-01-30 These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002 71335-0933-2 2024-01-30 These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002 71335-0933-3 2024-01-30 These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002 71335-0933-4 2024-01-30 These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002 71335-0933-5 2024-01-30 These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0933 EZETIMIBE TABLET [BRYANT RANCH PREPACK] 5 Current NDC, Legacy NDC, 5 package rows 20240517_11828685-dc27-42d8-a6ff-f110018207d1.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 71335-0933-4 71335093304 18 TABLET in 1 BOTTLE (71335-0933-4) 18 tablet 2021-12-28 0000-00-00 No No Current