Home NDC 33342-373 Ezetimibe
Product NDC 33342-373
11-digit product format 333420373
Labeler code 33342
Product ID 33342-373_ebe3fa4e-82c4-4a9a-9aec-f64019391f4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ezetimibe
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA211159
Marketing category ANDA
Marketing start 2024-04-29
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 A211159-001 EZETIMIBE EZETIMIBE 10MG TABLET / ORAL 2024-04-29
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.
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 A211159-001 EZETIMIBE 10MG TABLET / ORAL 2024-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211159-001 EZETIMIBE 10MG TABLET / ORAL 2024-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211159-001 EZETIMIBE 10MG TABLET / ORAL 2024-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211159-001 EZETIMIBE 10MG TABLET / ORAL AB 2024-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211159-001 EZETIMIBE 10MG TABLET / ORAL AB 2024-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211159-001 EZETIMIBE 10MG TABLET / ORAL AB 2024-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211159-001 EZETIMIBE 10MG TABLET / ORAL AB 2024-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211159-001 EZETIMIBE 10MG TABLET / ORAL AB 2024-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211159-001 EZETIMIBE 10MG TABLET / ORAL AB 2024-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211159-001 EZETIMIBE 10MG TABLET / ORAL AB 2024-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211159-001 EZETIMIBE 10MG TABLET / ORAL AB 2024-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211159-001 EZETIMIBE 10MG TABLET / ORAL AB 2024-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211159-001 EZETIMIBE 10MG TABLET / ORAL AB 2024-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211159-001 EZETIMIBE 10MG TABLET / ORAL AB 2024-04-29 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211159-001 EZETIMIBE 10MG TABLET / ORAL 2024-04-29 a50c72e98297…
Observed Orange Book normalized TE history# 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 33342-373-07 Ezetimibe 30 in 1 BOTTLE TABLET 30 1 33342-373-10 Ezetimibe 90 in 1 BOTTLE TABLET 90 1 33342-373-15 Ezetimibe 500 in 1 BOTTLE TABLET 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-373 EZETIMIBE TABLET [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 3 package rows 20240515_ebe3fa4e-82c4-4a9a-9aec-f64019391f4e.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 Sample Exclude flag Status 33342-373-07 33342037307 30 TABLET in 1 BOTTLE (33342-373-07) 30 tablet 2024-04-29 No No Current 33342-373-10 33342037310 90 TABLET in 1 BOTTLE (33342-373-10) 90 tablet 2024-04-29 No No Current 33342-373-15 33342037315 500 TABLET in 1 BOTTLE (33342-373-15) 500 tablet 2024-04-29 No No Current