Ezetimibe and Simvastatin
- Product NDC
- 45963-565
- 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
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 |
|---|
| 45963-565-08 | 45963056508 | 90 TABLET in 1 BOTTLE (45963-565-08) | 90 tablet | 2017-04-26 | 0000-00-00 | No | No | Current |
| 45963-565-30 | 45963056530 | 30 TABLET in 1 BOTTLE (45963-565-30) | 30 tablet | 2017-04-26 | 0000-00-00 | No | No | Current |