Home NDC 59651-837 Ezetimibe and Simvastatin
Product NDC 59651-837
11-digit product format 596510837
Labeler code 59651
Product ID 59651-837_0d4244dd-a226-4677-a6b2-6a1b5cd88790
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ezetimibe and Simvastatin
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA200082
Marketing category ANDA
Marketing start 2024-03-01
Substance EZETIMIBE; SIMVASTATIN
Active strength 10; 40 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 2026-12-31
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200082-001 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2020-12-17 A200082-002 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2020-12-17 A200082-003 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2020-12-17 A200082-004 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2020-12-17
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 4 · 148 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 2026-09-14 22:38:34 2026-08 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2020-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2020-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2020-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2020-12-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2020-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2020-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2020-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2020-12-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2020-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2020-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2020-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2020-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2020-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2020-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2020-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2020-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2020-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2020-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2020-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2020-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2020-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2020-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2020-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2020-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2020-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2020-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2020-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2020-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2020-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2020-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2020-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2020-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2020-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2020-12-17 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ezetimibe and Simvastatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EZETIMIBE 10 mg/1 SIMVASTATIN 40 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 · 4 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
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 59651-837-30 Ezetimibe and Simvastatin 30 in 1 BOTTLE TABLET 30 3 59651-837-90 Ezetimibe and Simvastatin 90 in 1 BOTTLE TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-837 EZETIMIBE AND SIMVASTATIN TABLET [AUROBINDO PHARMA LIMITED] 3 Current NDC, 2 package rows 20241025_79dadfde-35c7-4937-9c82-1728fb6be2fb.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 Sample Exclude flag Status 59651-837-30 59651083730 30 TABLET in 1 BOTTLE (59651-837-30) 30 tablet 2024-03-01 No No Current 59651-837-90 59651083790 90 TABLET in 1 BOTTLE (59651-837-90) 90 tablet 2024-03-01 No No Current