Home NDC 45963-568 Ezetimibe and Simvastatin
Product NDC 45963-568
11-digit product format 459630568
Labeler code 45963
Product ID 45963-568_ea5eedea-08bf-4180-8119-ed74e6365fae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ezetimibe and Simvastatin
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA202968
Marketing category ANDA
Marketing start 2017-04-26
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 · 42 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 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 45963-568-00 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 45963-568-00 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 45963-568-00 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 45963-568-00 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 45963-568-00 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 45963-568-00 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 45963-568-00 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 45963-568-00 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 45963-568-00 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 45963-568-00 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 45963-568-00 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 45963-568-00 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 45963-568-00 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 45963-568-00 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 45963-568-00 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 45963-568-00 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 45963-568-00 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 45963-568-00 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished product product 4bd3596a7b87…5c64c6f6865f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 45963-568-00 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 unfinished product product 263afe128892…91768de4ddbe…2019-12-08 06:16 UTC · source 2019-12-05 unfinished package package 45963-568-00 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 45963-568-00 5b2001dcd8f5…54b53d4dc9e4…
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 A202968-001 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET / ORAL 2017-04-26 A202968-002 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET / ORAL 2017-04-26 A202968-003 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET / ORAL 2017-04-26 A202968-004 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET / ORAL 2017-04-26
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 · 172 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 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL 2017-04-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL 2017-04-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL 2017-04-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL 2017-04-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL 2017-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL 2017-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL 2017-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL 2017-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45963-568 EZETIMIBE AND SIMVASTATIN TABLET [ACTAVIS PHARMA, INC.] 21 Legacy NDC 20250322_00680bea-d2fb-4362-ba67-e866b732e9ed.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 45963-568-08 45963056808 90 TABLET in 1 BOTTLE (45963-568-08) 90 tablet 2017-04-26 0000-00-00 No No Current 45963-568-30 45963056830 30 TABLET in 1 BOTTLE (45963-568-30) 30 tablet 2017-04-26 0000-00-00 No No Current