Home NDC 45963-565-30 Ezetimibe and Simvastatin
Product NDC 45963-565
Requested package NDC 45963-565-30
11-digit product format 459630565
Labeler code 45963
Product ID 45963-565_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 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 45963-565 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 45963-565-30 45963056530 30 TABLET in 1 BOTTLE (45963-565-30) 30 tablet 2017-04-26 0000-00-00 No No Current