Ezetimibe and Simvastatin
- Product NDC
- 43598-744
- 11-digit product format
- 435980744
- Labeler code
- 43598
- Product ID
- 43598-744_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
- 2027-10-31
- Substance
- EZETIMIBE; SIMVASTATIN
- Active strength
- 10; 20 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 table| Ingredient | Strength |
|---|
| EZETIMIBE | 10 mg/1 |
| SIMVASTATIN | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EOR26LQQ24, AGG2FN16EV |
| Rxcui | 476345, 476349, 476350, 476351 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-744-10 | Ezetimibe and Simvastatin | 1000 in 1 BOTTLE | TABLET | 1000 | | 10 |
| 43598-744-30 | Ezetimibe and Simvastatin | 30 in 1 BOTTLE | TABLET | 30 | | 10 |
| 43598-744-90 | Ezetimibe and Simvastatin | 90 in 1 BOTTLE | TABLET | 90 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-744 | EZETIMIBE AND SIMVASTATIN TABLET [DR.REDDYS LABORATORIES INC] | 8 | Current NDC, Legacy NDC, 3 package rows | 20201120_023ca87a-1b04-8c17-dc4f-e2758b0771e2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-744-10 | 43598074410 | 1000 TABLET in 1 BOTTLE (43598-744-10) | 1000 tablet | 2018-11-20 | 2027-10-31 | No | No | Current |
| 43598-744-30 | 43598074430 | 30 TABLET in 1 BOTTLE (43598-744-30) | 30 tablet | 2018-11-20 | 2027-10-31 | No | No | Current |
| 43598-744-90 | 43598074490 | 90 TABLET in 1 BOTTLE (43598-744-90) | 90 tablet | 2018-11-20 | 2027-05-31 | No | No | Current |