Home NDC 50090-8100 Ezetimibe
Product NDC 50090-8100
11-digit product format 500908100
Labeler code 50090
Product ID 50090-8100_2a79931f-8bdf-48d0-aeb3-59c1be7d5cd8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ezetimibe
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA210673
Marketing category ANDA
Marketing start 2020-10-23
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A210673-001 EZETIMIBE EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210673-001 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 2026-09-14 22:38:34 2026-08 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210673-001 EZETIMIBE 10MG TABLET / ORAL AB 2020-10-23 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ezetimibe EZETIMIBE ScieGen Pharmaceuticals Inc 11de499b-ad8a-46a6-9021-c8eba72ae414 2024-06-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 210673 application number: ANDA210673
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-8100-0 50090810000 30 TABLET in 1 BOTTLE (50090-8100-0) 30 tablet 2026-10-06 No No Historical 50090-8100-1 50090810001 90 TABLET in 1 BOTTLE (50090-8100-1) 90 tablet 2026-10-06 No No Historical