Home NDC 55289-280 VYTORIN
Product NDC 55289-280
11-digit product format 552890280
Labeler code 55289
Product ID 55289-280_d9a601bf-fa26-b6ba-e053-2995a90a42a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ezetimibe and simvastatin
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA021687
Marketing category NDA
Marketing start 2004-07-23
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 2023-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55289-280-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55289-280-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55289-280-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55289-280-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55289-280-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55289-280-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55289-280-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55289-280-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55289-280-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55289-280-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55289-280-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55289-280-30 557ba5c1ecfa…9c80585c8c6e…
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 N021687-001 VYTORIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET / ORAL AB RLD 2004-07-23 N021687-002 VYTORIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET / ORAL AB RLD 2004-07-23 N021687-003 VYTORIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET / ORAL AB RLD 2004-07-23 N021687-004 VYTORIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET / ORAL AB RLD, RS 2004-07-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 N021687-001 VYTORIN 10MG;10MG TABLET / ORAL AB RLD 2004-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021687-002 VYTORIN 10MG;20MG TABLET / ORAL AB RLD 2004-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021687-003 VYTORIN 10MG;40MG TABLET / ORAL AB RLD 2004-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021687-004 VYTORIN 10MG;80MG TABLET / ORAL AB RLD, RS 2004-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021687-001 VYTORIN 10MG;10MG TABLET / ORAL AB RLD 2004-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021687-002 VYTORIN 10MG;20MG TABLET / ORAL AB RLD 2004-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021687-003 VYTORIN 10MG;40MG TABLET / ORAL AB RLD 2004-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021687-004 VYTORIN 10MG;80MG TABLET / ORAL AB RLD, RS 2004-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021687-001 VYTORIN 10MG;10MG TABLET / ORAL AB RLD 2004-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021687-002 VYTORIN 10MG;20MG TABLET / ORAL AB RLD 2004-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021687-003 VYTORIN 10MG;40MG TABLET / ORAL AB RLD 2004-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021687-004 VYTORIN 10MG;80MG TABLET / ORAL AB RLD, RS 2004-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021687-001 VYTORIN 10MG;10MG TABLET / ORAL AB RLD 2004-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021687-002 VYTORIN 10MG;20MG TABLET / ORAL AB RLD 2004-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021687-003 VYTORIN 10MG;40MG TABLET / ORAL AB RLD 2004-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021687-004 VYTORIN 10MG;80MG TABLET / ORAL AB RLD, RS 2004-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021687-001 VYTORIN 10MG;10MG TABLET / ORAL AB RLD 2004-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021687-002 VYTORIN 10MG;20MG TABLET / ORAL AB RLD 2004-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021687-003 VYTORIN 10MG;40MG TABLET / ORAL AB RLD 2004-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021687-004 VYTORIN 10MG;80MG TABLET / ORAL AB RLD, RS 2004-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021687-001 VYTORIN 10MG;10MG TABLET / ORAL AB RLD 2004-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021687-002 VYTORIN 10MG;20MG TABLET / ORAL AB RLD 2004-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021687-003 VYTORIN 10MG;40MG TABLET / ORAL AB RLD 2004-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021687-004 VYTORIN 10MG;80MG TABLET / ORAL AB RLD, RS 2004-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021687-001 VYTORIN 10MG;10MG TABLET / ORAL AB RLD 2004-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021687-002 VYTORIN 10MG;20MG TABLET / ORAL AB RLD 2004-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021687-003 VYTORIN 10MG;40MG TABLET / ORAL AB RLD 2004-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021687-004 VYTORIN 10MG;80MG TABLET / ORAL AB RLD, RS 2004-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021687-001 VYTORIN 10MG;10MG TABLET / ORAL AB RLD 2004-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021687-002 VYTORIN 10MG;20MG TABLET / ORAL AB RLD 2004-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021687-003 VYTORIN 10MG;40MG TABLET / ORAL AB RLD 2004-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021687-004 VYTORIN 10MG;80MG TABLET / ORAL AB RLD, RS 2004-07-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021687-001 VYTORIN 10MG;10MG TABLET / ORAL AB RLD 2004-07-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021687-002 VYTORIN 10MG;20MG TABLET / ORAL AB RLD 2004-07-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021687-003 VYTORIN 10MG;40MG TABLET / ORAL AB RLD 2004-07-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021687-004 VYTORIN 10MG;80MG TABLET / ORAL AB RLD, RS 2004-07-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021687-001 VYTORIN 10MG;10MG TABLET / ORAL AB RLD 2004-07-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021687-002 VYTORIN 10MG;20MG TABLET / ORAL AB RLD 2004-07-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021687-003 VYTORIN 10MG;40MG TABLET / ORAL AB RLD 2004-07-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021687-004 VYTORIN 10MG;80MG TABLET / ORAL AB RLD, RS 2004-07-23 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ezetimibe ACTIVE INGREDIENT EOR26LQQ24 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 22 simvastatin ACTIVE INGREDIENT AGG2FN16EV VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 22 ezetimibe ACTIVE MOIETY EOR26LQQ24 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 22 simvastatin ACTIVE MOIETY AGG2FN16EV VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 22 butylated hydroxyanisole INACTIVE INGREDIENT REK4960K2U VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 22 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 22 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 22 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 22 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 22 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 22 magnesium stearate INACTIVE INGREDIENT 70097M6I30 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 22 propyl gallate INACTIVE INGREDIENT 8D4SNN7V92 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 22
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 VYTORIN EZETIMIBE AND SIMVASTATIN Organon LLC 89b860d2-de83-468e-b7e8-76aeec2edca2 2026-01-21 Warnings, Adverse reactions Exact identifier application applno (NDA): 021687 application number: NDA021687
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-280-30 55289028030 30 TABLET in 1 BOTTLE, PLASTIC (55289-280-30) 30 tablet 2011-11-01 0000-00-00 No No Current