ezetimibe and simvastatin
- Product NDC
- 16714-778
- 11-digit product format
- 167140778
- Labeler code
- 16714
- Product ID
- 16714-778_0d1ac067-fb51-46db-98da-5efd6a65e9e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ezetimibe and simvastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NORTHSTAR RX LLC
- Application
- ANDA208699
- Marketing category
- ANDA
- Marketing start
- 2019-08-19
- Substance
- EZETIMIBE; SIMVASTATIN
- Active strength
- 10; 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208699-001 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2019-06-27 | |
| A208699-002 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2019-06-27 | |
| A208699-003 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2019-06-27 | |
| A208699-004 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2019-06-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208699-001 | AB |
| A208699-002 | AB |
| A208699-003 | AB |
| A208699-004 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A208699-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2019-06-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208699-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2019-06-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208699-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2019-06-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208699-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2019-06-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208699-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2019-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208699-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2019-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208699-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2019-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208699-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2019-06-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208699-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2019-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208699-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2019-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208699-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2019-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208699-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2019-06-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208699-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2019-06-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208699-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2019-06-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208699-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2019-06-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208699-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2019-06-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208699-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2019-06-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208699-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2019-06-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208699-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2019-06-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208699-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2019-06-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208699-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2019-06-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208699-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2019-06-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208699-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2019-06-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208699-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2019-06-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208699-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2019-06-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208699-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2019-06-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208699-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2019-06-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208699-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2019-06-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208699-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2019-06-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208699-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2019-06-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208699-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2019-06-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208699-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2019-06-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208699-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2019-06-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208699-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2019-06-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208699-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2019-06-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208699-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2019-06-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208699-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2019-06-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208699-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2019-06-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208699-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2019-06-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208699-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2019-06-27 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A208699-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208699-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208699-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208699-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A208699-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208699-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208699-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208699-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208699-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208699-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208699-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208699-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208699-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208699-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208699-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208699-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208699-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208699-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208699-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208699-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208699-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208699-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208699-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208699-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208699-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208699-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208699-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208699-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208699-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208699-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208699-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208699-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208699-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208699-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208699-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208699-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208699-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208699-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208699-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208699-004 | AB | 1 | d8e5a09893c0… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5347abc9-d72b-9efb-f582-cc87efafcf1b | Product name | 4 | 20250729 |
| 91774e91-b249-45e3-8ff8-4b5db2927a69 | Product name | 1 | 20230718 |
| 93a156a6-903b-1690-4dc3-a57adfaa8c1a | Product name | 9 | 20230322 |
| c8f25656-847a-4de8-96a7-06bf98d83c2b | Product name | 1 | 20210916 |
| b249faa8-b784-47ef-8ad4-031ef248fa73 | Product name | 1 | 20200626 |
| c4422d73-8e69-1539-606a-32a25fa00ebc | Product name | 4 | 20190926 |
| 43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6 | Product name | 1 | 20160615 |
| 0a5e5249-329b-0cff-e714-77159f193a87 | Product name | 1 | 20140508 |
| 46fdf265-6d5a-1bfb-93db-d82a4ea8aa81 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16714-778-01 | ezetimibe and simvastatin | 30 in 1 BOTTLE | TABLET | 30 | 7 | |
| 16714-778-02 | ezetimibe and simvastatin | 90 in 1 BOTTLE | TABLET | 90 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16714-778-01 | EA - Each | 16714-778 | 1eed76d5-6e22-4952-85d8-a8fb72759a52 | 1 | 2019-11-12 |
| 16714-778-02 | EA - Each | 16714-778 | 33a6b669-a7ff-48eb-9e71-8e2c30a1ad9d | 1 | 2019-11-12 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ezetimibe and simvastatin | EZETIMIBE AND SIMVASTATIN | NORTHSTAR RX LLC | 52a46269-2262-4052-a3ff-5455523f591f | 2026-08-24 | Warnings, Adverse reactions | 208699 ANDA208699 16714-778 |
| ezetimibe and simvastatin | EZETIMIBE AND SIMVASTATIN | Glenmark Pharmaceuticals Inc., USA | 32d0e130-1211-44ca-be60-5379ffec96fd | 2024-04-30 | Warnings, Adverse reactions | 208699 ANDA208699 |
| ezetimibe and simvastatin | EZETIMIBE AND SIMVASTATIN | A-S Medication Solutions | 2c936363-b483-46c6-936c-a07d8ab0280c | 2024-01-16 | Warnings, Adverse reactions | 208699 ANDA208699 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 476345 | ezetimibe 10 MG / simvastatin 10 MG Oral Tablet | PSN | 52a46269-2262-4052-a3ff-5455523f591f | 7 |
| 476349 | ezetimibe 10 MG / simvastatin 20 MG Oral Tablet | PSN | 52a46269-2262-4052-a3ff-5455523f591f | 7 |
| 476350 | ezetimibe 10 MG / simvastatin 40 MG Oral Tablet | PSN | 52a46269-2262-4052-a3ff-5455523f591f | 7 |
| 476351 | ezetimibe 10 MG / simvastatin 80 MG Oral Tablet | PSN | 52a46269-2262-4052-a3ff-5455523f591f | 7 |
| 476345 | ezetimibe 10 MG / simvastatin 10 MG Oral Tablet | SCD | 52a46269-2262-4052-a3ff-5455523f591f | 7 |
| 476349 | ezetimibe 10 MG / simvastatin 20 MG Oral Tablet | SCD | 52a46269-2262-4052-a3ff-5455523f591f | 7 |
| 476350 | ezetimibe 10 MG / simvastatin 40 MG Oral Tablet | SCD | 52a46269-2262-4052-a3ff-5455523f591f | 7 |
| 476351 | ezetimibe 10 MG / simvastatin 80 MG Oral Tablet | SCD | 52a46269-2262-4052-a3ff-5455523f591f | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16714-778-01 | 16714077801 | 30 TABLET in 1 BOTTLE (16714-778-01) | 30 tablet | 2019-08-19 | 0000-00-00 | No | No | Current |
| 16714-778-02 | 16714077802 | 90 TABLET in 1 BOTTLE (16714-778-02) | 90 tablet | 2019-08-19 | 0000-00-00 | No | No | Current |