Home NDC 45963-567 Ezetimibe and Simvastatin
Product NDC 45963-567
11-digit product format 459630567
Labeler code 45963
Product ID 45963-567_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 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 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 4 · 132 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 2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202968-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2017-04-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202968-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2017-04-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202968-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2017-04-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202968-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2017-04-26 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 128 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45963-567 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 45963-567-08 45963056708 90 TABLET in 1 BOTTLE (45963-567-08) 90 tablet 2017-04-26 0000-00-00 No No Current 45963-567-30 45963056730 30 TABLET in 1 BOTTLE (45963-567-30) 30 tablet 2017-04-26 0000-00-00 No No Current