Home NDC 63629-7413 Ezetimibe
Product NDC 63629-7413
11-digit product format 636297413
Labeler code 63629
Product ID 63629-7413_359e02cb-5fc3-494a-9bf8-d2578aae8ee8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ezetimibe
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA203931
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 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 A203931-001 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 A203931-001 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 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203931-001 EZETIMIBE 10MG TABLET / ORAL AB 2017-06-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203931-001 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# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-7413 EZETIMIBE TABLET [BRYANT RANCH PREPACK] 4 Current NDC, Legacy NDC, 5 package rows 20240518_03609879-bad2-4e75-83fe-1e1a2fd300c3.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 · 3 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 63629-7413-1 63629741301 30 TABLET in 1 BOTTLE (63629-7413-1) 30 tablet 2017-10-10 0000-00-00 No No Current 63629-7413-2 63629741302 90 TABLET in 1 BOTTLE (63629-7413-2) 90 tablet 2017-10-10 0000-00-00 No No Current 63629-7413-3 63629741303 28 TABLET in 1 BOTTLE (63629-7413-3) 28 tablet 2024-04-03 0000-00-00 No No Current 63629-7413-4 63629741304 18 TABLET in 1 BOTTLE (63629-7413-4) 18 tablet 2024-04-03 0000-00-00 No No Current 63629-7413-5 63629741305 60 TABLET in 1 BOTTLE (63629-7413-5) 60 tablet 2024-04-03 0000-00-00 No No Current