Ezetimibe and Simvastatin
- Product NDC
- 45963-566
- Requested package NDC
- 45963-566-30
- 11-digit product format
- 459630566
- Labeler code
- 45963
- Product ID
- 45963-566_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
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 45963-566 | 45963-566-30 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | |
| 2024-11-08 22:44 UTC · 3 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 · 3 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 · 3 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 · 3 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202968-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202968-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202968-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202968-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202968-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202968-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202968-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202968-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202968-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202968-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202968-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202968-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202968-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202968-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202968-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202968-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202968-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202968-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202968-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202968-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202968-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202968-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202968-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202968-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202968-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202968-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202968-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202968-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202968-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202968-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202968-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202968-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202968-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202968-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202968-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202968-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202968-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202968-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202968-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202968-004 | AB | 1 | d06236e962d9… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45963-566-08 | EA - Each | 45963-566 | f79a05e3-2765-4f4a-8dd7-97d68721d4a1 | 1 | 2017-05-03 |
| 45963-566-30 | EA - Each | 45963-566 | 51f5e580-7624-420c-82c2-3b229f6a5819 | 1 | 2017-05-03 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 45963-566-30 | 45963056630 | 30 TABLET in 1 BOTTLE (45963-566-30) | 30 tablet | 2017-04-26 | 0000-00-00 | No | No | Current |