Home NDC 10135-787 Ezetimibe
Product NDC 10135-787
11-digit product format 101350787
Labeler code 10135
Product ID 10135-787_43046023-125e-85f6-e063-6294a90ab8c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ezetimibe
Dosage form TABLET
Route ORAL
Labeler Marlex Pharmaceuticals, Inc.
Application ANDA215693
Marketing category ANDA
Marketing start 2024-01-01
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 A215693-001 EZETIMIBE EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215693-001 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.
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 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215693-001 EZETIMIBE 10MG TABLET / ORAL 2022-09-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215693-001 EZETIMIBE 10MG TABLET / ORAL 2022-09-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215693-001 EZETIMIBE 10MG TABLET / ORAL 2022-09-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215693-001 EZETIMIBE 10MG TABLET / ORAL 2022-09-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215693-001 EZETIMIBE 10MG TABLET / ORAL 2022-09-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215693-001 EZETIMIBE 10MG TABLET / ORAL AB 2022-09-13 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 10135-787-05 Ezetimibe 500 in 1 BOTTLE TABLET 500 2 10135-787-30 Ezetimibe 30 in 1 BOTTLE TABLET 30 2 10135-787-90 Ezetimibe 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-787 EZETIMIBE TABLET [MARLEX PHARMACEUTICALS, INC.] 1 Current NDC, 3 package rows 20240207_109a22f4-a7cb-96c6-e063-6394a90ad7f6.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 · 2 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 10135-787-05 10135078705 500 TABLET in 1 BOTTLE (10135-787-05) 500 tablet 2024-01-01 No No Current 10135-787-30 10135078730 30 TABLET in 1 BOTTLE (10135-787-30) 30 tablet 2024-01-01 No No Current 10135-787-90 10135078790 90 TABLET in 1 BOTTLE (10135-787-90) 90 tablet 2024-01-01 No No Current