Home NDC 78206-175 VYTORIN
Product NDC 78206-175
11-digit product format 782060175
Labeler code 78206
Product ID 78206-175_9e668c78-ea5d-4099-ba16-b77aebbcb68a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ezetimibe and simvastatin
Dosage form TABLET
Route ORAL
Labeler Organon LLC
Application NDA021687
Marketing category NDA
Marketing start 2021-06-01
Substance EZETIMIBE; SIMVASTATIN
Active strength 10; 20 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 2027-12-31
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 · 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.
Additional Listing Data#
Finished product Yes
Brand name base VYTORIN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EZETIMIBE 10 mg/1 SIMVASTATIN 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EOR26LQQ24 Internal UNII lookup AGG2FN16EV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 476345 Internal RxNorm lookup 476349 Internal RxNorm lookup 476350 Internal RxNorm lookup 476351 Internal RxNorm lookup 1245420 Internal RxNorm lookup 1245430 Internal RxNorm lookup 1245441 Internal RxNorm lookup 1245449 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 78206-175-01 VYTORIN 30 in 1 BOTTLE TABLET 30 9 78206-175-02 VYTORIN 90 in 1 BOTTLE TABLET 90 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-175 VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [ORGANON LLC] 7 Current NDC, Legacy NDC, 2 package rows 20241123_89b860d2-de83-468e-b7e8-76aeec2edca2.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 · 1 matching rows.
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 78206-175-01 78206017501 30 TABLET in 1 BOTTLE (78206-175-01) 30 tablet 2021-06-01 0000-00-00 No No Current 78206-175-02 78206017502 90 TABLET in 1 BOTTLE (78206-175-02) 90 tablet 2021-06-01 0000-00-00 No No Current