Home NDC 50090-3984-0 Ezetimibe and Simvastatin
Product NDC 50090-3984
Requested package NDC 50090-3984-0
11-digit product format 500903984
Labeler code 50090
Product ID 50090-3984_61f1a059-0309-4d53-a8d8-ab73fbf6886c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ezetimibe and Simvastatin
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA208831
Marketing category ANDA
Marketing start 2018-09-24
Marketing end 0000-00-00
Substance EZETIMIBE; SIMVASTATIN
Active strength 10 mg/1; mg/1
Pharmacologic classes Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208831-001 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET / ORAL 2017-11-21 A208831-002 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET / ORAL 2017-11-21 A208831-003 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET / ORAL 2017-11-21 A208831-004 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET / ORAL 2017-11-21
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 5 · 164 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 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL 2017-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL 2017-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL 2017-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL 2017-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL 2017-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL 2017-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL 2017-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL 2017-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL 2017-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL 2017-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL 2017-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL 2017-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 148 observed states.
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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-3984-0 Ezetimibe and Simvastatin 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3984 EZETIMIBE AND SIMVASTATIN TABLET [A-S MEDICATION SOLUTIONS] 1 Legacy NDC, 1 package rows 20190103_fc205122-d66a-41cc-bfce-8e4c109f2f50.zip
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 50090-3984-0 50090398400 90 TABLET in 1 BOTTLE (50090-3984-0) 90 tablet 2018-12-17 0000-00-00 No No Current