ezetimibe and simvastatin
- Product NDC
- 50090-7047
- 11-digit product format
- 500907047
- Labeler code
- 50090
- Product ID
- 50090-7047_2a454f7c-e824-4504-b2e8-5fce64b1065a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ezetimibe and simvastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA208699
- Marketing category
- ANDA
- Marketing start
- 2019-08-19
- 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
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| EOR26LQQ24 | EZETIMIBE | 163222-33-1 | EZETIMIBE |
| AGG2FN16EV | SIMVASTATIN | 79902-63-9 | SIMVASTATIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7047-0 | 50090704700 | 90 TABLET in 1 BOTTLE (50090-7047-0) | 90 tablet | 2024-01-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ezetimibe and simvastatin | A-S Medication Solutions | 2024-01-16 | HUMAN PRESCRIPTION DRUG LABEL | 1 |