Home NDC 69238-1157-9 Ezetimibe and Simvastatin
Product NDC 69238-1157
Requested package NDC 69238-1157-9
11-digit product format 692381157
Labeler code 69238
Product ID 69238-1157_331b2e88-9d76-4e41-bca7-bcff0e206614
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ezetimibe and Simvastatin
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA208831
Marketing category ANDA
Marketing start 2017-11-21
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 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 3 · 116 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 2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 1e350fbaab3a…2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208831-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-11-21 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A208831-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-11-21 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A208831-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-11-21 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A208831-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-11-21 5aa47cf7b7d7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 112 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 69238-1157-3 Ezetimibe and Simvastatin 30 in 1 BOTTLE TABLET 30 13 69238-1157-9 Ezetimibe and Simvastatin 90 in 1 BOTTLE TABLET 90 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1157 EZETIMIBE AND SIMVASTATIN TABLET [AMNEAL PHARMACEUTICALS NY LLC] 13 Current NDC, Legacy NDC, 2 package rows 20250427_5ea3ca31-cfee-4978-8b7a-755986f6b091.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 69238-1157-9 69238115709 90 TABLET in 1 BOTTLE (69238-1157-9) 90 tablet 2017-11-21 0000-00-00 No No Current