Home NDC 66582-313-31 VYTORIN
Product NDC 66582-313
Requested package NDC 66582-313-31
11-digit product format 665820313
Labeler code 66582
Product ID 66582-313_601cfe1f-9a31-4f9d-85fb-27bad0191acf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ezetimibe and simvastatin
Dosage form TABLET
Route ORAL
Labeler Merck Sharp & Dohme Corp.
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 2022-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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 Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ezetimibe ACTIVE INGREDIENT EOR26LQQ24 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.] 43 simvastatin ACTIVE INGREDIENT AGG2FN16EV VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.] 43 ezetimibe ACTIVE MOIETY EOR26LQQ24 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.] 43 simvastatin ACTIVE MOIETY AGG2FN16EV VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.] 43 butylated hydroxyanisole INACTIVE INGREDIENT REK4960K2U VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.] 43 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.] 43 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.] 43 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.] 43 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.] 43 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.] 43 magnesium stearate INACTIVE INGREDIENT 70097M6I30 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.] 43 propyl gallate INACTIVE INGREDIENT 8D4SNN7V92 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.] 43 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 ezetimibe ACTIVE INGREDIENT EOR26LQQ24 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 simvastatin ACTIVE INGREDIENT AGG2FN16EV VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 ezetimibe ACTIVE MOIETY EOR26LQQ24 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 simvastatin ACTIVE MOIETY AGG2FN16EV VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 butylated hydroxyanisole INACTIVE INGREDIENT REK4960K2U VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 propyl gallate INACTIVE INGREDIENT 8D4SNN7V92 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 ezetimibe ACTIVE INGREDIENT EOR26LQQ24 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP] 1 simvastatin ACTIVE INGREDIENT AGG2FN16EV VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP] 1 ezetimibe ACTIVE MOIETY EOR26LQQ24 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP] 1 simvastatin ACTIVE MOIETY AGG2FN16EV VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP] 1 butylated hydroxyanisole INACTIVE INGREDIENT REK4960K2U VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP] 1 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP] 1 propyl gallate INACTIVE INGREDIENT 8D4SNN7V92 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP] 1
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
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 66582-313-31 66582031331 30 TABLET in 1 BOTTLE (66582-313-31) 30 tablet 2004-07-23 0000-00-00 No No Current