Ezetimibe and Simvastatin
- Product NDC
- 43598-743
- 11-digit product format
- 435980743
- Labeler code
- 43598
- Product ID
- 43598-743_697ae8a7-2359-455f-9c21-e266f1c31288
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ezetimibe and Simvastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr.Reddys Laboratories Inc
- Application
- ANDA200909
- Marketing category
- ANDA
- Marketing start
- 2018-11-20
- Marketing end
- 2027-09-30
- Substance
- EZETIMIBE; SIMVASTATIN
- Active strength
- 10; 40 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ezetimibe and Simvastatin
Active Ingredients#
| Ingredient | Strength |
|---|---|
| EZETIMIBE | 10 mg/1 |
| SIMVASTATIN | 40 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | AGG2FN16EV, EOR26LQQ24 |
| Rxcui | 476345, 476349, 476350, 476351 |
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 |
|---|---|---|---|---|---|---|
| 43598-743-05 | Ezetimibe and Simvastatin | 500 in 1 BOTTLE | TABLET | 500 | 10 | |
| 43598-743-30 | Ezetimibe and Simvastatin | 30 in 1 BOTTLE | TABLET | 30 | 10 | |
| 43598-743-90 | Ezetimibe and Simvastatin | 90 in 1 BOTTLE | TABLET | 90 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43598-743-05 | EA - Each | 43598-743 | c2074d2f-4cac-4b6a-92e7-a38c7132c46f | 1 | 2019-01-24 |
| 43598-743-30 | EA - Each | 43598-743 | 2cb97f0e-91fe-412f-8aa3-a1890f447eb3 | 1 | 2019-02-13 |
| 43598-743-90 | EA - Each | 43598-743 | 8b0909b6-73a8-4c51-a2bb-9356856bccdf | 1 | 2019-03-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 476345 | ezetimibe 10 MG / simvastatin 10 MG Oral Tablet | PSN | 023ca87a-1b04-8c17-dc4f-e2758b0771e2 | 10 |
| 476349 | ezetimibe 10 MG / simvastatin 20 MG Oral Tablet | PSN | 023ca87a-1b04-8c17-dc4f-e2758b0771e2 | 10 |
| 476350 | ezetimibe 10 MG / simvastatin 40 MG Oral Tablet | PSN | 023ca87a-1b04-8c17-dc4f-e2758b0771e2 | 10 |
| 476351 | ezetimibe 10 MG / simvastatin 80 MG Oral Tablet | PSN | 023ca87a-1b04-8c17-dc4f-e2758b0771e2 | 10 |
| 476345 | ezetimibe 10 MG / simvastatin 10 MG Oral Tablet | SCD | 023ca87a-1b04-8c17-dc4f-e2758b0771e2 | 10 |
| 476349 | ezetimibe 10 MG / simvastatin 20 MG Oral Tablet | SCD | 023ca87a-1b04-8c17-dc4f-e2758b0771e2 | 10 |
| 476350 | ezetimibe 10 MG / simvastatin 40 MG Oral Tablet | SCD | 023ca87a-1b04-8c17-dc4f-e2758b0771e2 | 10 |
| 476351 | ezetimibe 10 MG / simvastatin 80 MG Oral Tablet | SCD | 023ca87a-1b04-8c17-dc4f-e2758b0771e2 | 10 |
| 476345 | ezetimibe 10 MG / simvastatin 10 MG Oral Tablet | PSN | 88cd0e7b-e8dc-6125-e053-2a95a90aaa27 | 7 |
| 476349 | ezetimibe 10 MG / simvastatin 20 MG Oral Tablet | PSN | 88cd0e7b-e8dc-6125-e053-2a95a90aaa27 | 7 |
| 476350 | ezetimibe 10 MG / simvastatin 40 MG Oral Tablet | PSN | 88cd0e7b-e8dc-6125-e053-2a95a90aaa27 | 7 |
| 476351 | ezetimibe 10 MG / simvastatin 80 MG Oral Tablet | PSN | 88cd0e7b-e8dc-6125-e053-2a95a90aaa27 | 7 |
| 476345 | ezetimibe 10 MG / simvastatin 10 MG Oral Tablet | SCD | 88cd0e7b-e8dc-6125-e053-2a95a90aaa27 | 7 |
| 476349 | ezetimibe 10 MG / simvastatin 20 MG Oral Tablet | SCD | 88cd0e7b-e8dc-6125-e053-2a95a90aaa27 | 7 |
| 476350 | ezetimibe 10 MG / simvastatin 40 MG Oral Tablet | SCD | 88cd0e7b-e8dc-6125-e053-2a95a90aaa27 | 7 |
| 476351 | ezetimibe 10 MG / simvastatin 80 MG Oral Tablet | SCD | 88cd0e7b-e8dc-6125-e053-2a95a90aaa27 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43598-743-05 | 43598074305 | 500 TABLET in 1 BOTTLE (43598-743-05) | 500 tablet | 2018-11-20 | 0000-00-00 | No | No | Current |
| 43598-743-30 | 43598074330 | 30 TABLET in 1 BOTTLE (43598-743-30) | 30 tablet | 2018-11-20 | 2027-09-30 | No | No | Current |
| 43598-743-90 | 43598074390 | 90 TABLET in 1 BOTTLE (43598-743-90) | 90 tablet | 2018-11-20 | 2027-09-30 | No | No | Current |